Amgen Provides Regulatory Update On Status Of Lumakras; FDA Has Issued New Postmarketing Requirement; LUMAKRAS Dosing Confirmed At 960 mg Once-Daily For Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval
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Amgen announced that the FDA has completed its review of the supplemental New Drug Application for full approval of LUMAKRAS (sotorasib), resulting in a Complete Response Letter. The FDA issued a new postmarketing requirement for an additional confirmatory study to be completed by February 2028. The FDA confirmed the dosing of LUMAKRAS at 960 mg once-daily for patients with KRAS G12C-mutated NSCLC under accelerated approval. Over 15,000 patients have received LUMAKRAS worldwide through various programs.
December 26, 2023 | 2:03 pm
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NEUTRAL IMPACT
Amgen received a Complete Response Letter from the FDA regarding the full approval of LUMAKRAS, with a new postmarketing study requirement. The dosing of LUMAKRAS was confirmed, maintaining its current use under accelerated approval.
The FDA's Complete Response Letter and additional study requirement may be seen as a regulatory setback, potentially delaying full approval of LUMAKRAS. However, the confirmation of the current dosing regimen under accelerated approval suggests continued use and revenue from the drug in the short term. The impact on Amgen's stock price is likely to be neutral in the short term as the market digests the news and awaits further developments.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100