Chemotherapy Archives - Page 3 of 10

Bristol Myers Squibb’s Opdivo Combos Superior in Esophageal Cancer

Blockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, Combination Therapies, Esophageal Cancer, Esophageal Squamous Cell Carcinoma, R&D, Therapeutics, Topline Data

Bristol Myers Squibb announced topline data from the Phase III CheckMate -648 trial on April 8, with positive results in esophageal cancer.

April 9, 2021/by Andrew Humphreys

FDA Issues CRL to Merck

Acquisitions, 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.

March 30, 2021/by Andrew Humphreys

Novartis’ canakinumab failed to improve survival in Phase III trial

Chemotherapy, Clinical Trials, Metastatic non-small cell lung cancer, Monoclonal Antibodies, Novartis, R&D

Novartis’ drug canakinumab (ACZ885) did not meet the primary endpoint of overall survival in patients with advanced or metastatic non-small cell lung cancer in a Phase III study, but other late-stage trials are ongoing.

March 9, 2021/by Andrew Humphreys

FDA Approves G1 Therapeutics’ Cosela to Prevent Chemo Damage in Lung Cancer

Approvals, Bone Marrow, Chemotherapy, Chemotherapy-induced myelosuppression, Clinical Data, Clinical Trials, Extensive-Stage Small Cell Lung Cancer, FDA, FDA/Regulatory, Immune System, Myelosuppression, R&D, Therapeutics

The U.S. Food and Drug Administration approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy.

February 15, 2021/by Andrew Humphreys

FDA’s ODAC Votes Against Merck’s Keytruda For TNBC

Advisory 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.

February 10, 2021/by Andrew Humphreys

AstraZeneca’s Checkpoint Inhibitor Misses Mark in Head & Neck Cancer

AstraZeneca, Blockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, Head & Neck Squamous Cell Carcinoma (HNSCC), Overall Survival (OS), PD-1/PD-L1 inhibitors, Primary Endpoints, R&D, Therapeutics

AstraZeneca reported that the company’s Phase III KESTREL trial of Imfinzi (durvalumab) failed to meet the primary endpoint of improving overall survival compared to the EXTREME treatment regimen, which was chemotherapy plus cetuximab, a standard of care.

February 5, 2021/by Andrew Humphreys

Chemo Drug Potentially More Potent than Remdesivir Against Coronavirus

Antibiotics, Chemotherapeutics, Chemotherapy, China, Clinical Studies, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Drug screenings, Peripheral T-Cell Lymphoma (PTCL), PLOS Computational Biology, R&D, Remdesivir, Researchers, RNA, SARS-CoV-2 virus, Therapeutics

The chemotherapy pralatrexate and the antibiotic azithromycin were successful at preventing replication of the SARS-CoV-2 virus, according to research with Shenzhen Institutes of Advanced Technology in China.

January 5, 2021/by Andrew Humphreys

Aprea Therapeutics Reports Phase III Failure

Breakthrough Therapy, Business, Chemotherapy, Clinical Trial Endpoints, Clinical Trials, Combination Therapies, Myelodysplastic Syndromes, Orphan Drug Designation, Primary Endpoints, R&D, Shares, Small Molecules

Shares of Aprea Therapeutics plunged after the Boston-based company announced a late-stage cancer combination treatment failed to meet the primary endpoint of complete remission rate.

December 29, 2020/by Andrew Humphreys

U.S. FDA approves MacroGenics’ breast cancer drug

Advanced Breast Cancer, Approvals, Boxed Warning, Chemotherapy, Clinical Trials, FDA, R&D

The U.S. Food and Drug Administration approved MacroGenics Inc.’s drug Margenza in combination with chemotherapy for the treatment of an advanced type of breast cancer in patients who failed two or more prior therapies.

December 16, 2020/by Andrew Humphreys

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab

Biologics License Application (BLA), Bispecific Antibody, Clinical Trials, EGFR Mutations, Expanded Access Program (EAP), FDA, Metastatic non-small cell lung cancer, Platinum-Based Chemotherapy, R&D

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

December 3, 2020/by PR Newswire