Medical Technology

EU Panel Endorses First-of-Its-Kind Lung Cancer Drug

Europe has recommended approval for the first drug targeted at the KRAS variant in nonsmall cell lung cancer (NSCLC).

The European Medicines Agency’s Committee for Medicinal Products for Human Use, (CHMP), endorsed the new oral therapy called sotorasib (“Lumykras”) at its November meeting. The indication is the treatment of adults suffering from advanced NSCLC with a KRAS G12C mutation that has progressed after at least one prior line of systemic therapy.

Sotorasib is an inhibitor of KRAS G12C which is an oncogenic driver of tumorigenesis. The drug blocks cancer cell signaling and survival, slows cell growth, and selectively promotes apoptosis in tumors harboring KRAS G12C according to CHMP.

KRAS mutations are the most prevalent mutations in NSCLC cancers. However they’ve been resistant to treatment for a long period.

The KRAS G12C mutation is present in approximately 13 percent of NSCLC mutations.

When clinical data on sotorasib were presented at 2020 World Conference on Lung Cancer Experts in lung cancer welcomed the results with enthusiasm as reported by Medscape Medical News at the time.

“This is a significant breakthrough in lung cancer treatment. After 40 years of research on KRAS treatment, sotorasib could be the first targeted treatment option for this patient group with a large unmet medical demand,” Bob Li of Memorial Sloan Kettering Cancer Center, New York City said at the time.

Based on an investigation of 124 patients with locally advanced or metastatic G12C-mutated NSCLC the drug was approved by the US Food and Drug Administration in May. The study involved 124 patients who had received an inhibitor of the immune checkpoint or a platinum-based chemotherapy.

The FDA approved the drug on the basis of the overall response rate which was the main result of the study. Of the patients who responded 58% of them had a duration of response of at least 6 months.

According to the EMA, its recommendation for approval is based upon objective data on response rate and duration.

The most frequent side effects of Sotorasib include diarrhea and nausea.

Nick Mulcahy is an award-winning senior journalist for Medscape, focusing on oncology, and can be reached at [email protected] and on Twitter: @MulcahyNick

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