Clovis Oncology Inc (NASDAQ:CLVS) gets FDA’s breakthrough designation

Clovis Oncology Inc (NASDAQ:CLVS) got the FDA’s coveted breakthrough therapy designation for it’s in development treatment for ovarian cancer. The company got a speedy review for its therapy that was denied to rival Astrazenca plc (ADR) (NYSE:AZN).

Read what this analyst has to say about the fundamentals of CLVS.

The drug, called rucaparib, functions by inhibiting enzymes called poly ADP ribose polymerases (PARPs). The drug, therefore, gets in the way of the process that allows certain gene mutations to spread cancer throughout the body.

The FDA has given rucaparib its breakthrough tad for treatment of advanced ovarian cancer in patients with BRCA mutations. The move gives Clovis access to top agency officials while it works towards a filing and guaranteeing a truncated review once it submits the drug.

AstraZeneca had earlier tried to gain the breakthrough tag for its PARP inhibitor named Lynparza, however, it did not succeed. That makes Clovis’ drug the first in its class to get the breakthrough designation. AstraZeneca’s drug won an accelerated approval on the strength of Phase II data, and its long term fate depends on an on-going confirmatory study.

Clovis Oncology Inc (NASDAQ:CLVS) is set to follow a similar path. It has set sights on a 2016FDA filing based on Phase II results while enrolling a larger Phase III effort. If rucaparib is approved, then AstraZeneca’s drug will have a significant head start on the market. However, the preference of FDA for rucaparib might help Clovis gain ground.

Lynparza is a fourth line therapy whereas rucaparib is a third line one. AstraZeneca is expected to release new data this year that might support Lynparza’s full approval. However, it is unlikely to affect Clovis’ breakthrough tag.

According to Clovis’ CEO Patrick Mahaffy, the move by FDA is recognition of the encouraging response rate observed in women with the BRCA mutated advanced ovarian cancer when treated with rucaparib.

The news of the recognition set Clovis’ shares up 10% on Tuesday morning.

About the Author

Sally joined the US Markets Daily News Team in April 2011 as a Multimedia Journalist.

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