3 Biotechs With Cancer Drugs That Could Win Approval in 2017
October 10, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – Three companies developing cancer therapies are hoping to cross the finish line within the next year with regulatory approval of treatments. Clovis Oncology , Array BioPharma and Ariad Pharmaceuticals are preparing to make a bid for approval and investors should take note as it could mean big things for company stocks.
Clovis Oncology
Federal regulators are getting closer to green-lighting Clovis Oncology ’s ovarian cancer drug, rucaparib, a PARP inhibitor developed for the treatment of patients with platinum-sensitive, high-grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer. Phase II results were positive, particularly for women who have received at least two or more prior therapies—which means if approved, it could challenge AstraZeneca ’s Lynparza, which is the only approved treatment for women who have had three prior chemo treatments, the Motley Fool reported. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015. The FDA accepted rucaparib for priority review in August. In September, the U.S. Food and Drug Administration (FDA) opted to not hold an advisory committee meeting to discuss rucaparib—which was a great sign for the company, particularly after earlier failures with an experimental lung cancer drug. While the drug has opened eyes, Fool analysts notes that rucaparib has had some questions regarding its safety profile during trials, with 100 percent of patients having experienced an adverse event. That could become an issue with approval, Fool analyst Todd Campbell said.
Array BioPharma
On Sept. 1, the FDA accepted Array ’s New Drug Application for binimetinib for treatment of NRAS-mutant melanoma. The company is expected to meet with federal regulators this month to discuss the NDA package including clinical risk / benefit. Campbell noted that in clinical trials, patients taking binimetinib extended progression free survival in patients by more than a month for patients receiving chemotherapy treatment dacarbazine. However, when coupled with immunotherapy treatments, patients had stronger results. Campbell noted that patients taking binimetinib who had previously been treated with an immunotherapy such as Opdivo saw progression free survival of 5.5 months. The extension of life may not seem terribly long, but the patient population that binimetinib is aimed at treating has a poor prognosis.
Ariad Pharmaceuticals
Cambridge, Mass.-based Ariad Pharmaceuticals is hoping its lung cancer drug brigatinib will be able to carve out a preferred treatment spot in a global market worth nearly $750 million, Campbell said. The patient population for brigatinib is under 10,000 people. Trial data has shown that brigatinib has given progression-free survival of up to 12.9 months for patients. Currently in Phase III trials, brigatinib is going head-to-head against Pfizer ’s lung cancer drug, Xalkori (crizotinib), which was approved by the U.S. FDA in 2011. Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor. Brigatinib received Breakthrough Therapy designation from the U.S. FDA in October 2014. Ariad completed its rolling submission of New Drug Application for brigatinib at the end of August. The company said it plans to also submit an application for regulatory approval by the European Medicines Agency in early 2017.
While these three drugs look like they could make it to regulatory approval, Campbell noted that less than 10 percent of experimental cancer drugs make it to market, which means there are still hurdles to overcome for these companies.