Bristol-Myers Squibb’s Opdivo has become the first checkpoint inhibitor to be recommended for approval in the EU, grabbing a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for melanoma.
The EMA’s advisory committee recommended BMS’ PD-1 inhibitor for use as a first- and second-line therapy for patients with advanced (unresectable or metastatic) melanoma after an accelerated assessment.
The opinion is based on two phase III studies, one in treatment-naïve patients in which it was compared to the standard chemotherapy dacarbazine and the other in previously-treated patients, with Opdivo (nivolumab) plus chemotherapy compared to chemotherapy alone.
Opdivo was approved as a second-line treatment for melanoma in the US last December after being granted a broader license in Japan earlier in the year, and bagged a second FDA approval as a second-line non-small cell lung cancer (NSCLC) therapy – a much larger market opportunity – in March.
The CHMP opinion is another boost for BMS as it goes head-to-head in the checkpoint inhibitor market with rival Merck & Co, whose Keytruda (pembrolizumab) product is also approved for second-line melanoma therapy in the US and was recently filed for approval in NSCLC.
Neither BMS nor Merck has yet reported first-quarter results, which should give a first indication of how their respective drugs are faring the marketplace. Both companies are due to report their financials tomorrow.
Other CHMP opinions
Opdivo was one of 11 new medicine recommended for approval by the CHMP at its meeting last week.
Vanda Pharmaceuticals got the go-ahead for Hetlioz (tasimelteon) for the treatment of non-24-hour sleep wake disorder in totally blind adults – which was approved in the US last year – along with Daiichi Sankyo’s novel oral anticoagulant (NOAC) Lixiana (edoxaban), which has been available in Japan for some but got the green light from the FDA under the Savaysa brand name in January.
Other drugs receiving positive opinions included IDB’s radiopharmaceutical precursor LuMark (lutetium -177 chloride) for radiolabelling carrier molecules, along with several generic drugs. However, there was disappointment for Biovest Europe after its non-Hodgkin’s lymphoma therapy Lympreva (dasiprotimut-t) was turned down by the CHMP.
The panel said the way Lympreva’s main supportive study was designed and carried out was inadequate to allow it to establish the medicine’s benefit, and it also had concerns about some aspects of its manufacture and quality control.
Safety issue with new HCV drugs
The CHMP also said it had confirmed a risk of severe bradycardia or heart block when Gilead’s hepatitis C drug Harvoni (sofosbuvir with ledipasvir) – or a combination of Sovaldi (sofosbuvir) and BMS’ Daklinza (daclatasvir) – are used in patients who are also taking the antiarrhythmic drug amiodarone.
In patients taking these medicines, amiodarone should only be used if other anti-arrhythmics cannot be given, it recommends.