The Food and Drug Administration has delayed its decision until November on whether to grant expanded use of Bristol-Myers Squibb Co.'s cancer drug Opdivo.
The Princeton, N.J.-based, company said Wednesday the FDA pushed back its action date on the use of Opdivo for previously untreated advanced melanoma from Aug. 27 to Nov. 27.
In response, Bristol-Myers has submitted additional clinical trial data, which the company said constituted a “major amendment."
Opdivo received accelerated approval last December for the treatment of metastatic melanoma in cases where it cannot be removed through surgery or is no longer responsive to other drugs. In March the company was granted approval to expand its indication for the treatment of patients with advanced lung cancer.
Sales of the drug reached $162 million for the first six month of 2015, according to company documents. Experts project Opdivo will be a leader among a burgeoning class of immuno-oncology therapies valued at more than $30 billion in the coming years.
Shares of Bristol Myers were up $0.03 during late morning trading on Thursday to $62.42.