Bristol-Myers Squibb’s Opdivo recommended by CHMP in two indications

Bristol-Myers Squibb has announced that its new cancer drug Opdivo has been recommended for European approval in two indications.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo for adults with locally advanced or metastatic non-small cell lung cancer and advanced renal cell carcinoma, in both cases applying to patients who have already received a prior therapy.

Both of these recommendations are backed up by data from phase III clinical studies in which Opdivo demonstrated a survival benefit versus the current standard of care.

The drug is already approved in Europe for the treatment of advanced melanoma and previously treated advanced squamous non-small cell lung cancer.

Dr Michael Giordano, senior vice-president and head of development for oncology at Bristol-Myers Squibb, said: "We look forward to the European Commission's decision and the opportunity to bring an additional treatment option to these patients as quickly as possible."

It was recently announced that the availability of Opdivo in the UK is to be accelerated thanks to its inclusion in the Early Access to Medicines Scheme.