FDA Approves Osimertinib as Adjuvant Therapy for Non-Small Cell Lung Cancer with EGFR MutationsAs a service to our members, the American Association for Cancer Research will distribute information from the U.S. Food and Drug Administration about newly approved novel therapies for cancer patients. By doing so, we aim to help the FDA inform cancer researchers and oncologists of recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sharing this information, the AACR does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. On December 18, 2020, the Food and Drug Administration approved osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.Efficacy was demonstrated in a randomized, double-blind, placebo-controlled trial (ADAURA, NCT02511106) in patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC who had complete tumor resection, with or without prior adjuvant chemotherapy. Eligible patients with resectable tumors (stage IB – IIIA) were required to have predominantly non-squamous histology and EGFR exon 19 deletions or exon 21 L858R mutations identified prospectively from tumor tissue in a central laboratory by the cobas® EGFR Mutation Test. A total of 682 patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or placebo following recovery from surgery and standard adjuvant chemotherapy, if given.The major efficacy outcome measure was disease-free survival (DFS) in patients with stage II – IIIA NSCLC determined by investigator assessment. Median DFS was not reached (38.8, NE) in patients on the osimertinib arm compared with 19.6 months (16.6, 24.5) on the placebo arm (HR 0.17 95% CI: 0.12, 0.23; <0.0001). DFS in the overall study population was a secondary efficacy outcome measure; the median was not reached (NE, NE) in patients on the osimertinib arm compared with 27.5 months (22, 36) on the placebo arm (HR 0.20 95% CI: 0.15, 0.27; <0.0001).The recommended osimertinib dose for adjuvant treatment of early stage NSCLC is 80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years.Most common (>20%) adverse reactions in patients taking osimertinib, including laboratory abnormalities, were lymphopenia, leukopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.
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So another approval, this time for a drug where DFS (disease free survival) at 27.5 months in the PLACEBO arm. To my mind, that's not as urgent a need as anything for DIPG or GBM is.
If FDA is to be consistent, then sometime in 2021 Pax will be approved in combo with ONC-201 for DIPG.
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