BMS immunotherapy accepted for UK early access scheme

Patients in the UK with certain forms of lung cancer will be able to access Bristol-Myers Squibb’s immunotherapy Opdivo after the drug was approved by the Medicines and Healthcare products Regulatory Agency for the country’s Early Access to Medicines Scheme.

The move means that patients with locally advanced or metastatic squamous non-small cell lung cancer who have undergone a prior round of chemotherapy now have the option of treatment with Opdivo (nivolumab), ahead of an official green light for this use.

BMS’ Opdivo first EU approved PD-1 inhibitorEleven medicines leap closer to approval in EuropeB-MS halts Opdivo trial early on survival benefitUK names first drug in early access schemeUK to launch early access to drugs plan

It is looking likely that the drug will be cleared for use in NSCLC after it won the backing of the Committee for Medicinal products for Human Use last month, but EAMS status will accelerate access for patients in the meantime.

MHRA backing is based on data from from the Phase III CheckMate-017 study, which showed that treatment with Opdivo achieved a one-year overall survival rate of 42% versus 24% for the current standard of care docetaxel.

Also, median overall survival was 9.2 months vs 6.0 months, respectively, while treatment-related adverse events of grade 3-4 occurred less frequently with BMS’ drug.

Opdivo became the first PD-1 inhibitor to win clearance across Europe after regulators approved its use to treat skin cancer earlier this month.


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