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P T. 2018;43(9): 523-527, 557

Drug and Device News September 2018

NEW DRUG APPROVALS

Azedra for Rare Adrenal Tumors

The FDA has approved Azedra (iobenguane I 131, Progenics Pharmaceuticals) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare unresectable tumors of the adrenal gland (pheochromocytoma or paraganglioma) that have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use.

The efficacy of Azedra was shown in a single-arm, open-label, clinical trial in 68 patients that measured the number of patients who experienced a 50 percent or greater reduction of all antihypertensive medications lasting for at least 6 months. (Pheochromocytomas increase the production of epinephrine and norepinephrine, which leads to hypertension and other symptoms.)This endpoint was supported by the secondary endpoint, overall tumor response measured by traditional imaging criteria.

The most common severe side effects reported by patients in clinical trials included lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting.

As it is a radioactive therapeutic agent, Azedra includes a warning to patients about radiation exposure, which should be minimized while the patient is receiving the drug. The risk of radiation exposure is greater in pediatric patients.

The FDA granted this application Fast Track, Breakthrough Therapy and Priority Review designations. Azedra also received an Orphan Drug designation.

Source: FDA, July 30, 2018

Poteligeo Intravenous Injection for Non-Hodgkin Lymphoma

The FDA has approved Poteligeo (mogamulizumab-kpkc, Kyowa Kirin, Inc.) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.

Poteligeo is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.

The approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either Poteligeo or a type of chemotherapy called vorinostat. Progression-free survival was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat (median 3.1 months).

The most common side effects of treatment with Poteligeo included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection.

Serious warnings of treatment with Poteligeo include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation.

The FDA granted this application Priority Review and Breakthrough Therapy designation. Poteligeo also received Orphan Drug designation.

Source: FDA, August 8, 2018

Generic Approvals

Budesonide for Ulcerative Colitis

Actavis Laboratories has received permission to market budesonide extendedrelease tablets, 9 mg, the generic form of Uceris (Valeant Pharmaceuticals). Budesonide is used to induce remission in active, mild to moderate ulcerative colitis.

Source: FDA, July 5, 2018

Hydroxyprogesterone Caproate Injection for Preterm Birth

The FDA has granted permission to Luitpold Pharmaceuticals to produce hydroxyprogesterone caproate injection USP, 250 mg/mL, single-dose vials. The drug is used to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. AMAG Pharmaceuticals makes the brand-name drug, Makena.

Source: FDA, June 21, 2018

NEW INDICATION

Xtandi for Non-Metastatic Castration-Resistant Prostate Cancer

The FDA has approved Astellas Pharma’s supplemental new drug application for Xtandi (enzalutamide), based on results from the phase 3 PROSPER trial. The FDA action broadens the indication for Xtandi to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC.

This approval makes Xtandi the first and only oral medication that is FDA-approved for both non-metastatic and metastatic CRPC. Xtandi was first approved in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy- naïve men with metastatic CRPC.

PROSPER demonstrated that Xtandi plus androgen deprivation therapy (ADT) significantly reduced the risk of metastasis or death compared with ADT alone in men with non-metastatic CRPC. The median metastasis-free survival was 36.6 months for men who received Xtandi plus ADT versus 14.7 months with ADT alone.

Source: Astellas Pharma Inc., July 13, 2018

FDA ACTIONS

Priority Review Status

Keytruda for Advanced Hepatocellular Carcinoma

The FDA has granted priority review for a new supplemental biologics license application (sBLA) for Keytruda (pembrolizumab, Merck) as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). The sBLA is based on data from the phase 2 KEYNOTE-224 trial.

In the U.S., the incidence of liver cancer has more than tripled since 1980; an estimated 42,200 new cases of liver cancer will be diagnosed this year. Risk factors for liver cancer include chronic viral hepatitis B or C infection, cirrhosis, alcohol use and metabolic syndrome. HCC, which is frequently diagnosed at an advanced stage, has one of the highest mortality rates of solid cancers, with a five-year survival rate of less than 15%.

Keytruda, a humanized monoclonal antibody, works by increasing the immune system’s ability to detect and fight tumor cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.

The FDA has set a Prescription Drug User Fee Act date of November 9, 2018.

Source: Merck, July 11, 2018

Keytruda for Metastatic Squamous Non--Small-Cell Lung Cancer

The FDA has accepted for priority review a supplemental biologics license application for Keytruda (Merck) in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non--small-cell lung cancer (NSCLC), regardless of PD-L1 expression.

NSCLC is the most common type of lung cancer, accounting for about 85% of all cases. The five-year survival rate for patients diagnosed in the U.S. with any stage of lung cancer is estimated to be 18%.

The sBLA is based on data from the phase 3 KEYNOTE-407 trial. The FDA has set a Prescription Drug User Fee Act date of October 30, 2018.

Source: Merck, July 2, 2018

Glasdegib for Acute Myeloid Leukemia

The FDA has granted priority review for glasdegib (Pfizer), an investigational oral smoothened (SMO) inhibitor being evaluated in combination with low-dose cytarabine (LDAC) for adults with previously untreated acute myeloid leukemia.

Acute myeloid leukemia (AML) accounts for approximately 80% of all cases of acute leukemia. Despite recent advances, only approximately one in four patients with AML survive longer than five years. Additional treatment options are needed, particularly for patients who are unable to receive intensive chemotherapy and are triaged to other treatments associated with poorer outcomes.

Glasdegib is thought to inhibit the SMO receptor, thereby disrupting the Hedgehog pathway. Abnormal Hedgehog pathway activation may play a role in the development of multiple types of cancers, including solid tumors and hematologic malignancies.

The submission is based on results from the phase 2 BRIGHT 1003 study, a randomized, open-label, multicenter trial in which glasdegib plus LDAC significantly improved overall survival compared with LDAC alone (median, 8.8 months versus 4.9 months), reducing the risk of death by nearly 50%.

The Prescription Drug User Fee Act goal date is in December, 2018.

Source: Pfizer, June 27, 2018

Baloxavir Marboxil for Influenza

The FDA has granted Priority Review for baloxavir marboxil (Genentech) as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years of age and older. The FDA is expected to make a decision on approval by December 24, 2018.

Globally, annual influenza epidemics result in 3 to 5 million cases of severe disease, millions of hospitalizations, and up to 650,000 deaths. If approved, baloxavir marboxil would be the first oral, single-dose antiviral agent and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.

Baloxavir marboxil is a first-in-class medicine with a novel proposed mechanism of action to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other antiviral treatments, baloxavir marboxil is designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.

The FDA’s decision is based on results from the phase 3 CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for 5 days, in otherwise healthy people with the flu. Baloxavir marboxil significantly reduced the duration of flu symptoms, duration of fever, length of time of viral shedding, and levels of virus in the nose and throat. Results from a phase 2 study in otherwise healthy people with the flu are included as supporting data.

Baloxavir marboxil is being studied in an ongoing phase 3 development program including pediatric populations with influenza.

Source: Genentech, June 26, 2018

Imbruvica With Rituximab for Waldenström’s Macroglobulinemia

The FDA has accepted for Priority Review a supplemental new drug application (sNDA) by AbbVie for Imbruvica (ibrutinib) in combination with Rituxan (rituximab) as a new option for Waldenström’s macroglobulinemia (WM), a rare and incurable form of non-Hodgkin lymphoma. As a single-agent therapy, Imbruvica is the first and only FDA-approved treatment available for patients with WM. If approved, the sNDA would expand the prescribing information for Imbruvica in WM beyond its approved use as a single agent for all lines of therapy to include combination use with rituximab.

Imbruvica is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor. BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells, as well as other serious, debilitating conditions.

Imbruvica is already FDA-approved for patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, previously treated mantle cell lymphoma, previously treated marginal zone lymphoma, and previously treated chronic graft-versus-host disease.

The sNDA is supported by data from the phase 3 INNOVATE (PCYC-1127) trial assessing Imbruvica in combination with rituximab, versus rituximab alone, in patients with previously untreated and relapsed/refractory WM.

Source: AbbVie, June 25, 2018

Breakthrough Therapy Status

Tecentriq With Avastin for Advanced or Metastatic Hepatocellular Carcinoma

The FDA has granted Breakthrough Therapy designation to Genentech for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial treatment for people with advanced or metastatic hepatocellular carcinoma (HCC).

HCC, which accounts for approximately 75% of all liver cancer cases diagnosed in the U.S., develops predominantly in people with cirrhosis due to chronic hepatitis B or C. It typically presents at an advanced stage where there are limited treatment options.

The Breakthrough designation is based on data from a phase 1b study assessing the safety and clinical activity of the combination of Tecentriq and Avastin. After a median follow-up of 10.3 months, responses were seen in 15 (65%) of 23 efficacy- evaluable participants. Responses were seen in all subgroups, including on the basis of etiology (hepatitis B, hepatitis C and non-viral) and spread of tumor beyond the liver.

Tecentriq is a monoclonal antibody designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the reactivation of T cells. Tecentriq may also affect normal cells.

Avastin is a biologic antibody that binds to a protein called vascular endothelial growth factor (VEGF), which plays an important role throughout the life cycle of the tumor to develop and maintain blood vessels. By directly binding to the VEGF protein, Avastin prevents interactions with receptors on blood vessel cells. Avastin may enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumor infiltration and enabling priming and activation of T-cell responses against tumor antigens.

IMbrave150 (NCT03434379), an open-label, multicenter phase 3 study, is investigating the combination of Tecentriq and Avastin versus sorafenib in people with previously untreated locally advanced, unresectable or metastatic HCC.

Source: Genentech, July 18, 2018

Fast Track Designation

AGN-241751 for Major Depressive Disorder

The FDA has granted Fast Track designation for AGN-241751 (Allergan), an investigational new treatment for major depressive disorder (MDD).

More than 70% of patients with MDD are partial responders or nonresponders to first-line therapies, which include SSRIs and SNRIs. In addition, the STAR*D trial found that only 33% of patients reported remission of their MDD symptoms after monotherapy with an SSRI. Numerous clinical trials have also shown that, when patients do respond to an SSRI, it can take anywhere from two to four weeks for them to observe improvement. Moreover, patients with an incomplete response to traditional, monoamine-targeted therapies may continue to experience significant depressive symptoms, which can include suicidal ideation in patients with severe, recurrent, or chronic depression.

AGN-241751 is a novel, orally bioavailable, small molecule N-methyl-D-aspartate receptor (NMDAR) modulator. AGN-241751 development follows rapastinel, which modulates the NMDA receptor through a unique and novel binding site to enhance glutamatergic activity. Rapastinel has shown a rapid onset of antidepressant efficacy one day after a single dose in a phase 2 clinical trial of patients with MDD who had an inadequate response to one or more antidepressants.

Source: Allergan, July 23, 2018

Orphan Drug Designations

INZ-701 for ENPP1 Deficiency

Inozyme Pharma has been granted Orphan Drug designation for INZ-701, an enzyme-replacement therapy for the treatment of ENPP1 deficiency, a life-threatening calcification disorder.

The ENPP1 gene provides instructions for making a protein called ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1), which regulates inorganic pyrophosphate (PPi) levels in plasma. PPi is essential for preventing harmful soft tissue calcification and for regulating normal bone mineralization. ENPP1 deficiency manifests as either generalized arterial calcification of infancy (GACI) type 1 or autosomal recessive hypophosphatemic rickets type 2 (ARHR2). GACI type 1 is a devastating and often fatal disease affecting infants. It’s characterized by calcification and narrowing of large and medium-sized arteries, resulting in heart failure and death in about half of patients within the first six months of life. ARHR2 manifests in the post-infancy stage and causes rickets, weakened bones, repeated bone fractures, skeletal deformities, short stature, muscle weakness, fatigue, and bone pain.

In preclinical studies, INZ-701 has shown the potential to generate plasma PPi and restore it to appropriate physiological levels.

Inozyme is developing INZ-701 for other genetic disorders in which PPi levels are below the normal physiological levels.

Source: Inozyme, July 17, 2018

NiCord for Hematopoietic Stem Cell Transplantation

Gamida Cell has received Orphan Drug designation for NiCord as a treatment for hematopoietic stem cell transplantation. NiCord was previously granted Orphan Drug designation as a treatment for several hematologic malignancies.

NiCord is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. It has demonstrated improved efficacy over unmanipulated cord blood, including fewer bacterial and fungal infections and shorter hospital stays. A phase 3 study evaluating NiCord in patients with leukemia and lymphoma is ongoing.

Source: Gamida Cell, July 17, 2018

ACE-083 for Facioscapulohumeral Muscular Dystrophy

The FDA has granted Orphan Drug designation for ACE-083 (Acceleron Pharma) for the treatment of patients with facioscapulohumeral muscular dystrophy (FSHD).

ACE-083 is based on the naturally occurring protein follistatin, which uses the “Myostatin+” approach to inhibit multiple TGF-beta ligands. It is designed to have a concentrated effect along targeted muscles to maximize growth and strength selectively in the muscles into which the drug is administered.

Acceleron is developing ACE-083 for disorders in which improved muscle strength in targeted muscles may provide a clinical benefit and enhance quality of life. One of those is FSHD, a rare genetic muscle disorder affecting approximately 20,000 people in the U.S. The primary clinical presentation of FSHD is debilitating skeletal muscle weakness and loss. The symptoms develop in a descending “muscle by muscle” pattern, beginning with the face and upper body and progressing to the lower body.

ACE-083 is being evaluated in two phase 2 trials: one in FSHD and one in Charcot-Marie-Tooth disease. The final part 1 results from both trials are expected in the second half of 2018. Preliminary results from part 2 of the trial in patients with FSHD are expected in the second half of 2019.

Source: Acceleron Pharma Inc., July 12, 2018

OBI-3424 for Hepatocellular Carcinoma

OBI Pharma, Inc., has been granted Orphan Drug designation for OBI-3424, a first-in-class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 (AKR1C3) overexpressing cancers.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCCs), castration-resistant prostate cancer, and T-cell acute lymphoblastic leukemia.

HCC has a survival rate of around 12.2% for five years. While most liver cancers are preventable, the incidence of HCC has recently increased in the United States, possibly due to the prevalence of common risk factors such as chronic liver disease, viral liver infections such as hepatitis, and cirrhosis. HCC patients also have a high risk of developing drug resistance to standard-of-care treatments, creating a need for alternative treatment.

OBI-3424 is a small-molecule prodrug that selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are nonselective.

A phase 1/2 study of OBI-3424 in patients with solid tumors has begun enrollment.

Source: OBI Pharma, July 9, 2018

ASN120290 for Progressive Supranuclear Palsy

Asceneuron SA has received Orphan Drug designation for ASN120290 for the treatment of progressive supranuclear palsy (PSP).

PSP is a neurological condition in which toxic aggregates of the tau protein accumulate in the brain in neurofibrillary tangles. Neurofibrillary tangles are widely recognized as a key driver of neurodegeneration and clinical symptoms, such as problems with balance and speech, in the majority of dementia cases, including Alzheimer’s disease. It is estimated that 3 to 6 people per 100,000 will develop PSP. There is currently no cure.

ASN120290 is a selective inhibitor of the O-GlcNAcase enzyme. Based on its unique mechanism of action, the molecule has the potential to become a first-in-class treatment for PSP and other tau-related dementias. The therapeutic potential of ASN120290 has been demonstrated in preclinical studies with a substantial reduction in the build-up of tau aggregates.

ASN120290 has recently completed a randomized, double-blind, placebo-controlled phase 1 study to assess its safety and tolerability of single and multiple doses in healthy young and elderly volunteers.

Source: Asceneuron SA, July 18, 2018

New Drug Applications

REC-994 for Cerebral Cavernous Malformation

The FDA has cleared an investigational new drug application for a phase 1 clinical trial of REC-994 (Recursion) in the treatment of the genetic disease cerebral cavernous malformation (CCM).

CCM is a genetic disease affecting up to 1.5 million people in the U.S. CCMs are collections of small blood vessels that are enlarged and irregular. While CCMs can occur anywhere in the body, approximately 60,000 patients develop them in the brain, leading to seizures, vision and hearing loss, paralysis, other focal neurologic deficits and/or hemorrhagic stroke due to the altered blood flow.

REC-994 is a potent selective superoxide dismutase mimetic, a mechanism of action that has preclinical proof of concept to affect lesion development.

Source: Recursion, July 10, 2018

RDD-0315 for Fecal Incontinence in Spinal Cord Injury

The FDA has cleared the investigational new drug application for RDD-0315 (RDD Pharma), a topical treatment for fecal incontinence in patients with spinal cord injury.

More than 200,000 spinal cord injury patients and an estimated 20 million non-institutionalized adults in the U.S. suffer from fecal incontinence. Loss of bowel control, whether due to neurodegenerative disease, diabetes, age-related changes, or other cause, significantly disrupts quality of life, but treatment options are limited.

Positive phase 2a results indicate a statistically significant reduction in the number of fecal incontinence episodes at 8 and 12 hours post-administration.

The phase 1 clinical study is anticipated to produce data by the fourth quarter of 2018.

Source: RDD Pharma, July 17, 2018

Two New Voluntary Programs For Quality Metrics

The FDA has announced 2 new voluntary programs—the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program—in response to stakeholder requests for continued information and feedback on quality metrics, and to provide methods for industry to engage and inform the FDA’s use of them in the future. According to Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), and Michael Kopcha, Director of the Office of Pharmaceutical Quality at CDER, the programs will also help manufacturers gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.

Feedback from early adopters and manufacturers who implemented quality metrics programs to address manufacturing problems indicated that a manufacturer’s overall quality program benefited from the use of quality metrics. These metrics, such as data on the rate at which manufactured lots have been rejected for failing to meet established standards, can help manufacturers monitor quality control systems and drive continuous improvement efforts; they can also help the FDA better assess risk when scheduling inspections. This has the potential to decrease the frequency of surveillance inspections for lower-risk establishments and to narrow the focus of on-site inspections conducted.

The proximal causes of many drug shortages are quality issues such as substandard manufacturing facilities or processes. Quality metrics can be useful in identifying situations in which a drug supply disruption may occur; metrics can help mitigate potential future drug shortages. This will help to reassure patients that quality medicines will be available when they need them.

The Quality Metrics Feedback Program solicits information from drug manufacturers and sponsors that have implemented and are currently using quality metrics programs.

The purpose of the Quality Metrics Site Visit Program is to provide on-site, firsthand learning opportunities to the FDA staff involved in the development of the FDA Quality Metrics Feedback Program. The Site Visit Program also is intended to provide stakeholders with the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.

Source: FDA Voice blog, July 26, 2018

FDA Takes Steps to Encourage Development of Opioid Addiction Drugs

The FDA has issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). Recently issued draft guidance outlines new ways for drug developers to measure and demonstrate the effectiveness and benefits of new or existing MAT products. This new draft guidance is part of a larger effort to promote more widespread development, access to and adoption of MAT.

MAT for opioid dependence relies on prescription drugs, including buprenorphine, methadone and naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. Regular adherence to MAT helps patients gain control over their use of opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. MAT, coupled with social, medical and psychological services, is a highly effective treatment for OUD. Patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.

Clinical trials to evaluate the effectiveness of MAT for potential FDA approval have generally used reduction in drugtaking behavior as an endpoint. The new draft guidance identifies several additional endpoints and other outcome measures that manufacturers may consider.

In the guidance, the FDA encourages drug sponsors to consider a variety of ways to evaluate the effect and clinical benefit of MAT. These include the impact of a new drug on adverse outcomes like mortality, emergency medical interventions and hepatitis C seroconversion. Efficacy may also be measured by studying the proportion of patients who transition from meeting criteria for being diagnosed with moderate to severe OUD—based on both drug use and its impact on patient well-being—at baseline to being considered in remission at the end of the study. Improvements in the ability to resume work, school, or other productive activity may also demonstrate clinical benefit.

As part of HHS’ Five-Point Strategy to Combat the Opioid Crisis, the FDA is working to addressing the epidemic on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction by taking new steps to encourage more appropriate prescribing; supporting the treatment of those with OUD and promoting the development of improved and lower cost forms of MAT; fostering the development of novel pain treatment therapies that may not be as addictive as opioids, and opioids more resistant to abuse and misuse; and taking action against those who illegally import and sell opioid products.

Source: FDA, August 6, 2018

DRUG NEWS

Pfizer R&D Spending Increases To Accelerate Blockbuster Drug Approvals

Pfizer Inc. plans to increase research and development spending for the remainder of the year in an ambitious plan to accelerate the delivery of potential blockbuster treatments to market.

The drugmaker raised projections for spending on research to $7.7 billion to $8.1 billion from $7.4 billion and $7.9 billion previously. With a 26% increase in net income, Pfizer expects between 25 and 30 drugs from its pipeline to be approved through 2022.

Sales of Pfizer’s off-patent brands and generic drugs fell in the last quarter, and sales of Lyrica, its fibromyalgia drug, dipped 3% to $1.2 billion. Pfizer also lost trademark exclusivity for Viagra, and sales for that drug fell 47% over the past year to $185 million.

Source: Wall Street Journal, July 31, 2018

Women Still More Likely to Get Genetic Testing for Cancer Risk

A recent study in JAMA Oncology found that U.S. women were more likely to get tested for inherited gene mutations associated with cancer risk, despite the fact that women and men who carry inherited BRCA gene mutations associated with increased cancer risk have an equal chance of passing them on to their children. Women received genetic testing for hereditary cancer risk three times more often than men, according to the study. When it came to genetic testing for mutations associated with hereditary breast and ovarian cancer syndrome, such as BRCA1 and BRCA2, the gender gap was even greater: women were 10 times more likely to get tested than men.

Men are at higher risk for developing a number of cancers including melanoma and pancreatic cancer. Doctors and researchers are launching new efforts to address the testing disparity, starting with men who may already have medical issues or a family history of cancer.

The National Comprehensive Cancer Network recently modified guidelines to include a recommendation that men with metastatic prostate cancer should consider genetic testing. Researchers at Fred Hutchinson Cancer Research Center and the University of Washington launched the Gentlemen study, offering free genetic testing to 2,000 men with advanced prostate cancer to determine if they have inherited mutations linked to increased cancer risk.

Some researchers say genetic testing for men has lagged behind testing for women because scientists still don’t know enough about which mutations increase men’s cancer risk, or by how much. Previous studies indicate that men are generally less likely than women to go to the doctor. Some researchers believe social factors also play a significant role in the testing gap.

Source: Wall Street Journal, August 7, 2018