On Tuesday Clovis Oncology (CLVS) announced that the FDA panel had completely shot down its lung cancer drug due to insufficient data. The panel voted 12-1 against the recommendation for Rociletinib approval. This is not a good thing, because now the company must await until there phase 3 trial is complete to potentially resubmit data for approval. 

The company was hoping that the FDA would grant the company accelerated approval for the lung cancer drug. Unfortunately, the panel didn't see the drugs pathway in that manner. The panel wanted more evidence that Rociletinib can perform better against chemotherapy. It's a shame the company didn't get accelerated approval, as it would have been able to market the drug on a conditional approval basis. 

With the recognition of accelerated approval it could have potentially started selling the drug by the end of this year. It must now await data from a large phase 3 trial, which is not expected to readout until 2018. Then the company must once again file approval to the FDA, so when all is said and done that would put a potential approval around 2019. 

The FDA will ultimately decide whether to approve the drug or not, but considering the huge landslide vote against approval things don't look good. While the FDA doesn't have to take into consideration the panels' recommendation, they typically tend to agree with it. The FDA decision is expected to come in at June 28. 

Rociletinib is a drug from Clovis designed to treat a rare form of lung cancer with a T7090M mutation that helps the cancer evade current therapies. What really hurt Clovis is the fact that AstraZeneca (AZN) had recently received approval of a drug targeting the same lung cancer population. Astrazeneca's drug Tagrisso won accelerated approval for the U.S. back in November 2015. This could be one of the reason's why the FDA panel was so harsh against Rociletinib. The mixed data, and harsher side effects of the drug didn't help the cause either.

Whether Clovis chooses to continue the drug remains to be seen. The good news out of this is that the company at leas has other drugs in the pipeline. Such other drugs in the pipeline target ovarian cancer and breast cancer. With those indications the company may slightly redeem itself, but the lung cancer indication is a larger market then these other two.