The FDA has informed Clovis Oncology, Inc., that it is not planning to hold an advisory committee meeting to discuss the company’s new drug application (NDA) for rucaparib. The company is seeking approval of the drug for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors who have been treated with two or more chemotherapies. The treatment has already received breakthrough therapy and priority review designations, which speed up the review process.
Clovis completed its NDA submission of rucaparib to the FDA in June 2016, and the agency accepted the documents in August.
According to one analysis, the FDA’s decision to forego an advisory panel review suggests that the agency has not found any issues with the drug that would require outside opinion––a good sign.
Rucaparib is an oral, small-molecule inhibitor of poly ADP ribose polymerase-1 (PARP1), PARP2, and PARP3 that is being developed for the treatment of patients with advanced ovarian cancer. Specifically, rucaparib is being developed as monotherapy for advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test) who have been treated with two or more chemotherapies.
In addition, rucaparib is being studied in the ARIEL3 trial as maintenance therapy for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA (known as homologous recombination deficiencies [HRD]). Data from the ARIEL3 study are expected in the fourth quarter of 2017, which will be followed by the submission of a supplemental NDA for second-line maintenance therapy.
Clovis is also exploring rucaparib in other solid tumor types with BRCA and HRD populations, including prostate, breast, and gastroesophageal cancers.
The efficacy of rucaparib was assessed in two multicenter, single-arm, open-label trials in a total of 106 patients with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. The patients’ median age was 59 years, and the median number of prior chemotherapy regimens was three. The first study was limited to platinum-sensitive patients, and the second study included platinum-sensitive, platinum-resistant, and platinum-refractory patients.
All 106 patients received the starting dosage of rucaparib 600 mg twice daily. The primary efficacy outcome measures in both trials were the objective response rate (ORR) and the duration of response (DOR). The overall ORR was 54% (9% complete response rate plus 45% partial response rate), and the median DOR was 9.2 months (range, 6.6 to 11.6 months).
In May, Clovis stopped work on another experimental cancer drug, rociletinib, after it appeared that the FDA was set to reject it.
Sources: FierceBiotech(link is external); September 9, 2016; Market Exclusive(link is external); September 9, 2016; and Clovis Oncology; August 23, 2016.
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