Opdivo first lung cancer drug approved for UK's Early Access to Medicines Scheme

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the investigational PD-1 (programmed death-1) immune checkpoint inhibitor, Opdivo (nivolumab), from US Pharma major Bristol-Myers Squibb (NYSE: BMY).

Opdivo has been approved as a treatment option of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. Granted to therapies which are deemed to offer significant advantages over other medicines, today’s decision marks the first ever positive scientific opinion for a lung cancer therapy under this innovative scheme, the company noted.

Market potential

Analysts have estimated that Opdivo will generate peak global sales of around $5 billion, and Leerink's Seamus Fernandez believes its potential in lung cancer will take it as high as $7.3 billion by 2020. The drug was approved for the melanoma indication in the USA late last year (TPL December 23, 2014). Opdivo generated $40 million in worldwide revenue during the first quarter of 2015.

The UK decision will enable eligible patients to access nivolumab ahead of its marketing authorization in lung cancer, from the European Commission. Last month, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending European approval of nivolumab as a treatment option for locally advanced or metastatic squamous NSCLC after prior chemotherapy in adults (The Pharma Letter May 22); once it has been licensed by the European Commission, the EAMS closes to new participants. Those already enrolled will continue to be provided with the treatment.