FDA Action Alert: Bristol Myers Squibb and Trevena

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August is a busy month on the U.S. Food and Drug Administration (FDA)s calendar. Here’s a look at this week’s schedule.

Bristol Myers Squibb’s Opdivo & Yervoy for Non-Small Cell Lung Cancer

Bristol Myers Squibb had a target action date of August 6, 2020 for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This was granted Fast Track designation. The agency approved it on May 27, 2020.

The application was based on data from the Phase III CheckMate -9LA clinical trial. The company indicated that trial had met its primary endpoint of superior overall survival (OS) at a pre-specified interim analysis.

“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” said Sabine Maier, development lead, thoracic cancers, Bristol Myers Squibb, in an April 2020 statement. “The FDA’s acceptance and EMA’s validation of our applications represent important milestones for patients with lung cancer, and we look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”

The reference to the European Medicines Agency (EMA) is an announcement also made in April that the EMA had validated the company’s type II variation application for the Opdivo plus Yervoy combination with limited chemotherapy for the same indication. That validation confirmed that the application was complete and the EMA was beginning its centralized review process.

On March 26, Bristol Myers Squibb and Ono Pharmaceutical submitted a supplemental application for the combination and the same indication to Japan’s regulatory authority.

At the approval, Adam Lenkowsky, general manager and head of Bristol Myers Squibb’s Oncology, Immunology, and Cardiovascular US branch said, “Non-small cell lung cancer is a complex disease that requires multiple treatment options to address the needs of different patient populations. This second approval of an (nivolumab and ipilimumab)o-based combination for the first-line treatment of advanced NSCLC now gives more patients access to a dual immunotherapy approach that can be administered with or without limited chemotherapy, depending on the patient and their PD-L1 status, and the possibility of a longer chance to live longer.”

Trevena’s Oliceridine for Moderate-to-Severe Acute Pain

Chesterfield, Pennsylvania-based Trevena has a target action date of August 7 for oliceridine for management of moderate-to-severe acute pain. The company resubmitted the New Drug Application (NDA) to the FDA and it was accepted for review on February 10, 2020.

The drug was originally rejected by the FDA in November 2018, three weeks after an FDA advisory committee voted 8 to 7 against the drug. The drug was given the brand name Olinvo, and its mechanism of action is different than conventional opioids, utilizing a different pathway to relieve pain but without the respiratory and gastrointestinal side effects seen in other drugs. The committee, however, did not believe there was enough safety data to support the company’s proposed dosing regimen, with briefing documents released ahead of the committee meeting say the drug has “abuse potential, overdose potential and ability to produce physical dependence that is similar to other (opioids).”

The FDA’s complete response letter “requested additional clinical data on QT prolongation and indicated that the submitted safety database is not adequate size for the proposed dosing,” Trevena issued in a statement at the time.

The company resubmitted the NDA based on the outcome and final minutes of a Type A meeting with the FDA. The resubmitted package included data from the multi-dose healthy volunteer QT trial, nonclinical data confirming inactive metabolite levels, and drug product validation reports. The resubmission also identified a maximum daily dose of 27 mg, which was previously acknowledged by the FDA in the Type A meeting minutes. No additional efficacy data or comparative data compared to IV morphine was requested as part of the CRL.

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