Dishman Pharma shares hit all-time high on FDA nod for cancer drug

The FDA has approved a new drug for treating advanced ovarian, fallopian tube, and primary peritoneal cancers.

"The effectiveness of platinum-based chemotherapy diminishes over time, and PFS and platinum-free intervals generally become shorter after each round of platinum therapy". Like the AstraZeneca drug, Clovis's PARP blocker was approved for patients who have BRCA mutations.

Treatment with Zejula reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations. It has been cleared for prescription to patients with relapsed or recurrent tumors that have demonstrated sensitivity to platinum-type chemotherapy. Patients were assigned to one of two cohorts based on the BRACAnalysis CDx, with those having deleterious or suspected deleterious germline BRCA mutations (gBRCAm) assigned to the germline BRCA-mutated (gBRCAmut) cohort (n=203), and those without germline BRCA mutations assigned to the non-gBRCAmut cohort (n=350).

"Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment", said Richard Pazdur, director of the FDA's Oncology Center of Excellence. The median progression-free survival for patients taking Zejula who had a germline BRCA mutation was 21 months compared to 5.5 months for similar patients on placebo. Adverse effects of Zejula include anemia, thrombocytopenia, neutropenia or leukopenia, heart palpitations, nausea, constipation, vomiting, distention, diarrhea, mucositis, indigestion, dry mouth, fatigue, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension. Approximately 1.4% of patients also experienced myelodysplastic syndrome or acute myeloid leukemia, sometimes occurring simultaneously, while 1.1% of placebo patients developed the conditions. Niraparib was previously granted fast track designation in September 2016 by the FDA, and was granted priority review in December 2016. "We are so gratified to bring this unique new medicine to women with ovarian cancer, and would like to thank the patients who gave selflessly to participate in this trial with the assistance of their caregivers and physicians".

Zejula will also not require a patient selection with a biomarker test, a blow for Myriad Genetics, which had argued that its companion diagnostic test would be needed to select patients.

Tesaro will continue to study the drug's capabilities for breast cancer treatment while expanding research into other forms of cancer.

The company did not announce a price for the drug, but expects to launch at the end of April.

  • Joanne Flowers