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.
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.
In the RELATIVITY-047 Phase II/III trial combining Bristol Myers Squibb’s Opdivo with the anti-LAG-3 antibody relatlimab, the drug mashup met the study’s primary goal for progression-free survival compared to use of the blockbuster brand alone in metastatic melanoma patients.
After touting positive results in December and August 2020 for the company’s Phase III cancer medicine for metastatic breast cancer, Odonate Therapeutics is discontinuing drug development and closing up shop.
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.
Breast cancer overtook lung cancer as the most common form of the disease, accounting for nearly 12% of new cases each year worldwide, the World Health Organization said.
BioSpace reviewed the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years.
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.
Boehringer Ingelheim is paying 1.18 billion euros ($1.5 billion) for Swiss-based NBE Therapeutics as the German drugmaker is adding pipeline candidates including a drug in early trials against triple-negative breast cancer and lung cancer.
MacroGenics Inc. announced a partnership with Eversana to commercialize margetuximab in the United States, if approved.
