Amgen Says FDA Oncologic Drugs Advisory Committee (ODAC) Will Review Data Supporting Supplemental New Drug Application (sNDA) For Full Approval Of LUMAKRAS (sotorasib) At Meeting On Oct. 5, 2023
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Amgen announced that the FDA Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for full approval of LUMAKRAS (sotorasib) on October 5, 2023. LUMAKRAS received accelerated approval from the FDA on May 28, 2021, and the sNDA for full approval was accepted for standard review with a target action date of December 24, 2023.
August 21, 2023 | 8:02 pm
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Amgen's LUMAKRAS is set for review by the FDA's ODAC for full approval. This follows its accelerated approval in May 2021. The review date is set for October 5, 2023, with a target action date of December 24, 2023.
The news of the FDA's review for full approval of LUMAKRAS is directly related to Amgen and its product. This could potentially lead to increased investor confidence and a positive impact on the stock price in the short term, given the importance of FDA approvals for pharmaceutical companies.
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