The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened last month.
Last month, the US Food and Drug Administration approved three new drugs, as well as a potentially practice-changing cancer screening tool, and expanded indications for two agents. The FDA also placed a partial hold on a phase 3 lung cancer trial and a drug company voluntarily withdrew its bladder cancer drug. to treat advanced gastric cancer in the first-line setting. Zolbetuximab — the first claudin 18.
Approval was based on two trials, which showed a median overall survival benefit of 2.2-2.7 months in patients who received zolbetuximab plus chemotherapy vs placebo plus chemotherapy. in the first-line setting alongside palbociclib and fulvestrant to treat advanced breast cancer in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor -positive, HER2-negative disease after recurrence on or after adjuvant endocrine therapy.
The approval was based on the INAVO120 trial, which found patients in the inavolisib arm demonstrated a median progression-free survival benefit about two times longer than those in the placebo group. as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients aged ≥ 12 years who have hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.
Noncolorectal Gi Cancer U.S. Food And Drug Administration United States Food And Drug Administration Fda Breast Cancer Malignant Breast Neoplasm Breast Carcinoma Cancer Malignant Neoplasia Carcinoma Malignant Neoplasm Lung Cancer Lung Carcinoma Cancer Of The Lung Colorectal Cancer Colorectal Cancer (CRC) Small Cell Lung Cancer
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