AstraZeneca said on March 24 the company’s drug Imfinzi, along with chemoradiotherapy, failed to achieve the main goal of improving survival in patients with locally advanced cervical cancer without the disease worsening.
Bristol Myers Squibb’s Opdualag – a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion – was approved by the U.S. Food and Drug Administration for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
After Karyopharm Therapeutics Inc. submitted Phase III data from the Massachusetts-based pharmaceutical company’s SIENDO study on selinexor, the U.S. Food and Drug Administration said it was unlikely to support a supplemental New Drug Application approval for the drug.
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
Novartis said on Oct. 25 the company’s canakinumab drug failed in another clinical trial, missing targets to improve overall survival rates for lung cancer patients and prevent the progression-free survival of people with the condition.
Positive final results from the Phase III COSMIC-311 trial for Cabometyx (cabozantinib) were reported by Exelixis for patients diagnosed with previously treated radioactive iodine-refractory differentiated thyroid cancer.
In MacroGenics’ SOPHIA Phase III study in adults with metastatic HER2-positive breast cancer, the biopharmaceutical company’s Margenza plus chemotherapy failed to show a statistically significant advantage when compared to trastuzumab plus chemotherapy in the intent-to-treat population.
Topline results from the Phase III TULIP study show an antibody-drug conjugate (ADC) from the Netherlands-based Byondis B.V. significantly prolonged progression-free survival (PFS) in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
An experimental Bristol Myers Squibb drug from a new class of immunotherapy used in combination with the company’s big-selling cancer medicine Opdivo significantly extended the time it took for advanced melanoma to worsen compared with Opdivo alone, according to early data from a study released on May 19.
The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
