Merck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) at the virtual 2021 Genitourinary Cancers Symposium of the company’s checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma.
Amicus Therapeutics announced topline results from the Phase III PROPEL pivotal trial of AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease.
Bristol Myers Squibb and Exelixis announced results from new analyses from the pivotal Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).
Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.
Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration for the first-line treatment of patients with advanced renal cell carcinoma.
The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
Roche presented updated data confirming the Swiss drugmaker’s immunotherapy Tecentriq, used in combination with Avastin, substantially improves overall survival in people with the most common form of liver cancer.
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.
Relay Therapeutics entered a global license and collaboration agreement with Genentech for the commercialization and development of RLY-1971, a potent inhibitor of SHP2.
The U.S. Food and Drug Administration granted Emergency Use Authorization to a combination of Eli Lilly’s and Incyte’s rheumatoid arthritis drug Olumiant (baricitinib) and Gilead Sciences’ remdesivir as a treatment for hospitalized patients diagnosed with Covid-19 who require supplemental oxygen or ventilation.