Merck announced the publication of results from the Phase 3 KEYNOTE-522 trial in the Feb. 10, 2022 edition of the New England Journal of Medicine. Results showed that neoadjuvant Keytruda in combination with chemotherapy followed by adjuvant Keytruda as monotherapy, significantly prolonged event-free survival compared with neoadjuvant chemotherapy followed by adjuvant placebo in patients with high-risk early-stage triple-negative breast cancer (TNBC).
Gilead Combo Therapy Hit with FDA Hold Over Serious Adverse EventsAcute Myeloid Leukemia (AML), CD47 Protein, Clinical Trials, Combination Therapies, Diffuse large B-cell lymphoma (DLBCL), FDA/Regulatory, Gilead, Head & Neck Squamous Cell Carcinoma (HNSCC), Malignancies, Myelodysplastic Syndromes, Partial Clinical Hold, R&D, Triple Negative Breast Cancer (TNBC)
The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
Researchers at the Cleveland Clinic are set to launch a Phase I trial for what could be the first-ever vaccine to prevent triple-negative breast cancer.
Roche Holding AG decided to withdraw the company’s immunotherapy Tecentriq as a treatment for a type of breast cancer in the United States, the drugmaker said on Aug. 26 following a consultation with the Food and Drug Administration.
The common over-the-counter drug aspirin might be the key to finding a viable treatment method for breast cancer.
After an earlier rejection from the U.S. Food and Drug Administration, Merck’s vaunted checkpoint inhibitor Keytruda won approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer.
FDA Committee Supports Maintaining Accelerated Approval of Tecentriq in PD-L1+ mTNBCAccelerated Approval, Blockbusters, Checkpoint Inhibitors, FDA, Genentech, Oncologic Drugs Advisory Committee (ODAC), PD-1/PD-L1 inhibitors, Recommended For Approval, Therapeutics, Triple Negative Breast Cancer (TNBC)
A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
The U.S. Food and Drug Administration granted full approval to Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
FDA Issues CRL to MerckAcquisitions, Agreements, Blockbusters, Business, Chemotherapy, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, Keytruda, Merck, Metastatic Urothelial Carcinoma (mUC), PD-1/PD-L1 inhibitors, Spin-offs, Therapeutics, Triple Negative Breast Cancer (TNBC)
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
FDA’s ODAC Votes Against Merck’s Keytruda For TNBCAdvisory Committees, Blockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, Early-Stage Triple-Negative Breast Cancer (TNBC), FDA, FDA, High-Risk, Keytruda, Not Recommended For Approval, Oncologic Drugs Advisory Committee (ODAC), R&D, Therapeutics
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.