Opdivo set to be first PD-1 approved in Europe

Bristol-Myers Squibb’s (BMS) new cancer immunotherapy Opdivo has been recommended by Europe’s CHMP committee – just one step away from final approval.

The regulatory committee has recommended approval of Opdivo (nivolumab) for adults with advanced (unresectable or metastatic) melanoma, and the decision means BMS’ drug will be the first of the rival PD-1/PD-L1 immunotherapies to hit the European market.

The CHMP decision puts Opdivo ahead of its closest rival, Merck’s Keytruda (pembrolizumab), which was the first to gain approval in the US in September last year for melanoma.

The two companies are competing in a number of other cancer types, most notably non-small cell lung cancer (NSCLC), in which BMS was the first to gain US approval in March this year.

Analysts predict these two frontrunners in the PD-1/PD-L1 immunotherapy field will hit peak sales of around $6-7 billion or more.

Other CHMP recommendations

The decision on Opdivo was just one of 11 drugs recommended by the CHMP on Friday, four of them novel medicines and seven new generic entrants.

The first of three other novel drugs recommended was Vanda Pharmaceuticals’ Hetlioz (tasimelteon), a new treatment for non-24-hour sleep-wake disorder in adults who are totally blind. The drug, which was granted orphan status in 2011, is a melatonin receptor agonist and acts as a circadian regulator that resets the master body clock.

Daiichi Sankyo’s Lixiana (edoxaban) also received a positive opinion for prevention of stroke and systemic embolism in atrial fibrillation, and the prevention and treatment of venous thromboembolism. The drug is the fourth in the class of novel oral anticoagulants, following Bayer’s Xarelto, Boehringer Ingelheim’s Pradaxa and Pfizer/BMS’ Eliquis.

Radiopharmacy’s LuMark (Lutetium (177Lu) chloride), a radiopharmaceutical precursor, received a position opinion for radiolabelling of carrier molecules.

The seven generic approvals were in just three active ingredients – aripiprazole in schizophrenia, duloxetine in depression and pregabalin in a number of indications.

Negative opinion and extensions

There was just one negative CHMP opinion, on Biovest Europe’s Lympreva (dasiprotimut-T) which was intended for patients with follicular non-Hodgkin’s lymphoma. The CHMP said that the way the main clinical trial was designed and carried out was ‘inadequate’ to allow it to establish the medicine’s benefit. The CHMP also had some concerns about the manufacture and quality control of the medicine.

Meanwhile there were recommended extensions of indication for six drugs: Esmya, Invega, Levemir, Relistor, Resolor and Tygacil.

Hepatitis C drugs with amiodarone warning

Finally, the CHMP also issued a warning about the risk of severe bradycardia or heart block in patients receiving new hepatitis C medicines alongside anti-arrhythmic treatment amiodarone.

The warning covers when Gilead’s Harvoni (sofosbuvir with ledipasvir) or a combination of Gilead’s Sovaldi (sofosbuvir) and BMS’ Daklinza (daclatasvir) are used in patients who are also taking amiodarone. The CHMP has recommended that amiodarone should only be used if other antiarrhythmics cannot be given.

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