FDA Requests Additional Study For Amgen's Lumakras
According to the reports in the media, the U.S. health regulator has opted not to grant traditional approval to Amgen's Lumakras for the treatment of lung cancer patients with a specific gene mutation. However, the drug will retain its existing accelerated approval status, as announced on Tuesday.
The U.S. Food and Drug Administration (FDA) has stipulated the need for data from an additional confirmatory study to support Lumakras's full approval. Amgen has committed to completing this study no later than February 2028. Lumakras received initial approval from the FDA in 2021 under an accelerated pathway, with the requirement of confirmatory data for traditional approval.
Amgen reported that its previous confirmatory study demonstrated a 34 per cent reduction in the risk of disease progression in advanced lung cancer patients compared to chemotherapy. However, there was no significant variance in overall survival. In October, an FDA advisory committee voted 10 to two, expressing scepticism about relying on the main goal of the late-stage study to assess the drug's benefits.
Key concerns during the committee's discussions centred on the perceived allowance of too many patients to switch between the treatment and control arms of the study.
Lumakras, an oral drug, is specifically designed to target a mutated form of the KRAS gene, occurring in approximately 13 per cent of non-small cell lung cancers, the most prevalent form of lung cancer, and less frequently in some other solid tumours.
A comparable drug, Krazati from Mirati Therapeutics, received accelerated FDA approval late last year for patients with advanced lung cancer testing positive for the KRAS mutation. Notably, Amgen's Lumakras recorded sales totalling USD 199 million in the first nine months of this year, a slight decrease from USD 214 million in the corresponding period of 2022. Meanwhile, Bristol Myers Squibb is closely monitoring developments in the field.
