No. 1: Rucaparib
Rucaparib is a PARP inhibitor developed by Clovis Oncology that is being considered for approval by the FDA under the priority review pathway as a treatment for patients with a BRCA-mutated ovarian cancer.
In phase 2 studies, patients receiving rucaparib had an overall response rate of 54%. That's important because the patient population studied in rucaparib's trials had already tried and failed on a median three chemotherapies. 39% of patients had received two prior therapies and 61% of patients had received three or more prior therapies. As a result, rucaparib could become the first PARP drug approved for use in patients who have previously received two therapies. Currently, Lynparza, which won approval in 2014, is only approved for use in patients who have received at least three chemotherapies.
Rucaparib's efficacy appears solid, however, there are some questions regarding the drug's safety and that means an approval isn't a sure bet. In trials, 100% of patients experienced an adverse event and 61% experienced a severe adverse event (grade 3 or higher).
Rucaparib's safety profile could derail an approval, but investors should remember that there's a significant unmet need for new treatment options for pre-treated ovarian cancer patients. Since it appears that dose interruption and dose reduction can effectively manage rucaparib's safety risks, an approval could still be likely.
No. 2: Binimetinib
Binimetinib is under FDA review for the treatment of NRAS-mutant melanoma. Array Biopharma's application for binimetinib was accepted by the FDA for review in September and an official go/no-go decision is anticipated next June.
In trials, patients receiving binimetinib had progression-free survival of 2.8 months versus 1.5 months for patients receiving the chemotherapy dacarbazine. Binimetinib patients that had previously been treated with an immunotherapy, such as Opdivo, had progression free survival of 5.5 months, versus 1.6 months for patients receiving dacarbazine. Also, the confirmed overall response rate was 15% for binimetinib and just 7% for dacabazine.
That efficacy may not sound like a substantial improvement, but this patient population has a very poor prognosis and since binimetinib was well-tolerated in trials, an FDA OK next summer is a good possibility. If the FDA does give binimetinib the nod, then it could become a welcome new alternative for the 20% of melanoma patients with NRAS-mutant melanoma. Last year, roughly 15,000 Americans were diagnosed with NRAS-melanoma.
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