AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Compass Therapeutics and AstraZeneca have both provided updates to their respective clinical therapeutic programs targeting biliary tract cancers.
Novartis announced positive news for patients with metastatic breast cancer. New data showed Kisqali (ribociclib), in combination with the chemotherapy drug fulvestrant, added nearly 16 months of survival benefit to the lives of patients compared to fulvestrant alone.
Bayer’s Nubeqa drug won priority review status from the U.S. Food and Drug Administration, as the German drugmaker seeks to widen the use of the prostate cancer drug from an early disease stage to metastatic cases.
China-based Hutchmed failed to get the U.S. Food and Drug Administration’s approval for the company’s proposed drug for pancreatic cancer.
A collaboration between Gilead Sciences and Dragonfly Therapeutics was announced May 2, with an end goal of bringing Dragonfly’s DF7001 natural killer (NK) engager program designed for patients with cancer or inflammatory diseases to fruition.
The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.
EVERSANA, the pioneer of next-generation commercial services to the global life sciences industry, and Vector Pharma FZCO of Dubai UAE, the leading full-service distributor for rare disease, oncology and highly specialized therapeutics in the Middle East, North Africa and Turkish markets, announced a strategic partnership to expand services across the Middle East and North African markets.
Nektar Therapeutics outlined a strategic reorganization plan that includes cutting 70 percent of the company’s workforce, only weeks after Bristol Myers Squibb abandoned its clinical collaboration program with Nektar on bladder cancer and renal cell carcinoma.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Reuters