publication date: Oct. 9, 2020
Drugs & Targets
Opdivo + Yervoy receive FDA approval in mesothelioma indication
Opdivo (nivolumab) in combination with Yervoy (ipilimumab) received FDA approval for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
Opdivo and Yervoy are sponsored by Bristol-Myers Squibb.
This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma.
“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”
With currently available therapy, overall survival is generally poor for malignant pleural mesothelioma. Opdivo and Yervoy are both monoclonal antibodies that, when combined, decrease tumor growth by enhancing T-cell function.
This combination therapy was evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM. Patients received intravenous infusions of Opdivo every two weeks with intravenous infusions of Yervoy every six weeks for up to two years, or platinum-doublet chemotherapy for up to six cycles.
Treatment continued until disease progression, unacceptable toxicity or completion of two years. The objective was to determine if Opdivo in combination with Yervoy improved overall survival compared to chemotherapy. At the time of the analysis, patients who received Opdivo in combination with Yervoy survived a median of 18.1 months while patients who underwent chemotherapy survived a median of 14.1 months.
The review was conducted under Project Orbis. FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies. FDA approval occurred approximately five months ahead of the goal date.
Regeneron asks FDA for emergency clearance for COVID-19 therapy
Regeneron has submitted a request to FDA for Emergency Use Authorization approval for the
REGN-COV2 investigational antibody combination for COVID-19.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2. The agent was recently used to treat President Donald Trump.
If an EUA is granted, the government has committed to making these doses available at no cost, and would be responsible for their distribution.
At this time, there are doses available for approximately 50,000 patients. Regeneron said it expects to have doses available for 300,000 patients in total within the next few months.
FDA issues draft guidance that encourages inclusion of premenopausal women in breast cancer clinical trials
FDA has issued draft guidance encouraging the inclusion of premenopausal women in breast cancer clinical trials that investigate the efficacy of hormonal drug and biological products.
When finalized, the guidance will provide recommendations for industry to generate additional data that will support the efficacy and safety of drugs and biologics for premenopausal women with breast cancer.
Historically, premenopausal women have been excluded from clinical trials that investigated the efficacy of hormonal drugs for the treatment of hormone positive breast cancer, largely due to concerns about potential differences in how these hormonal drug and biological products would behave in premenopausal versus postmenopausal women. This exclusion resulted in delays in availability of these therapies for premenopausal women.
“We believe that with sufficient estrogen suppression, hormonal drug and biological products are likely to have similar efficacy and safety in premenopausal women as in postmenopausal women. Therefore, premenopausal women should be included in these clinical trials,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Once finalized, we hope that the recommendations in the draft guidance will encourage expanded drug development for the treatment of breast cancer in premenopausal women,” he said.