Three companies developing cancer therapies are hoping to win nods from the FDA next year. Clovis Oncology, Array BioPharma, and Ariad Pharmaceuticals are all awaiting approval responses, according to a report from BioSpace.
The FDA is nearing a decision on Clovis’ ovarian cancer treatment rucaparib, a poly ADP ribose polymerase (PARP) enzyme inhibitor developed for the treatment of women with platinum-sensitive, high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian-tube cancer. Phase 2 study results for rucaparib were positive, especially in women who had received at least two prior therapies—which means that if rucaparib is approved, it could challenge AstraZeneca’s olaparib (Lynparza), which is indicated only for women who have had three prior chemo treatments, according to BioSpace
The FDA granted a breakthrough therapy designation for rucaparib in April 2015 and accepted the drug for priority review in August 2016. In September, the agency announced that it would not hold an advisory committee meeting to discuss rucaparib—which was viewed as a good sign. In clinical trials, however, 100% of patients treated with rucaparib experienced adverse events, which might complicate the approval process.
In September 2016, the FDA accepted Array BioPharma’s new drug application (NDA) for binimetinib for the treatment of patients with NRAS-mutant melanoma. Array is scheduled to meet with the agency this month to discuss its NDA package, including the risk–benefit ratio of binimetinib. In clinical studies, binimetinib extended progression-free survival (PFS) by more than one month compared with the chemotherapy treatment dacarbazine. Patients receiving binimetinib who had been treated with an immunotherapeutic, such as nivolumab (Opdivo, Bristol-Myers Squibb), experienced PFS of 5.5 months.
Ariad Pharmaceuticals is hoping that its investigational lung cancer drug brigatinib will become the preferred treatment for patients with anaplastic lymphoma kinase positive (ALK+) non–small-cell lung cancer (NSCLC) whose disease is resistant to crizotinib (Xalkori, Pfizer/EMD Serono)––a population of less than 10,000 people. In clinical trials, brigatinib has provided PFS of up to 12.9 months. The treatment is currently going head-to-head with crizotinib in phase 3 studies. Brigatinib received a breakthrough therapy designation from the FDA in October 2014. Ariad completed its rolling submission of an NDA for brigatinib in August 2016.
Source: BioSpace; October 10, 2017.