Clovis Oncology, Inc. CLVS announced that rucaparib received Breakthrough Therapy status from the FDA as monotherapy for advanced ovarian cancer in patients with BRCA-mutated tumors (inclusive of both germline BRCA and somatic BRCA mutations), who received at least two prior lines of platinum-containing therapy.
Breakthrough Therapy designation for a candidate allows the company developing it to enjoy all the features of fast track status in addition to intensive guidance from the FDA for the development of the candidate.
Currently, rucaparib is being evaluated in several studies including the Assessment of Rucaparib in Ovarian Cancer Trial (ARIEL) program, which includes the phase II ARIEL2 treatment study and the phase III ARIEL3 maintenance study in ovarian cancer patients. At the Annual Meeting on Women’s Cancer held last week, Clovis Oncology presented a positive update from the ARIEL2 study. Data showed that rucaparib led to encouraging activity and safety in patients suffering from advanced, platinum-sensitive ovarian cancer with gBRCA and sBRCA mutations. The candidate was generally well-tolerated by the patients.
Meanwhile, Clovis Oncology expanded the ARIEL2 study into a registration study (to enroll about 300 patients whose disease recurred after at least three prior lines of chemotherapy). On the basis of data from this study, the company plans to submit a new drug application for rucaparib for the treatment of ovarian cancer in 2016. Simultaneously, Clovis Oncology intends to complete patient enrolment in the global ARIEL3 pivotal study by 2016.
Apart from rucaparib, the company is developing two other candidates, rociletinib (non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations, as well as the primary resistance mutation, T790M) and lucitanib (breast and lung cancers). Both candidates are under phase II development.
We note that Clovis Oncology bagged Breakthrough Therapy status for two of its oncology candidates. In May 2014, rociletinib was granted this designation by the FDA for the treatment of EGFR mutation-positive non-small cell lung cancer in patients whose disease progressed after EGFR-directed therapy due to T790M-mediated acquired drug resistance.
Clovis Oncology carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP, Horizon Pharma plc HZNP and Cytokinetics, Incorporated CYTK. All these stocks carry a Zacks Rank #1 (Strong Buy).
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