Tags : Breakthrough Therapy Designation

Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to

Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical […]Read More

Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US

Shots: The US FDA’s BT designation is based on an ongoing P-II DESTINY-Lung01 study assessing Enhertu in 170 patients with HER2 mutant or HER2 overexpressing unresectable and m-nsq. NSCLC, progressed after one or more systemic therapies including CT, molecular targeted therapy or immunotherapy and data from P-I study, published in Cancer Discovery The overall safety […]Read More

Eli Lilly and Incyte’s Olumiant (baricitinib) Receives the US FDA’s

Shots: The FDA’s BT designation is based on P-II results of P-II/III BRAVE-AA1 study assessing baricitinib vs PBO in patients with AA The P-II portion of the BRAVE-AA1 study demonstrated no new safety signals with no SAEs @36wks. Additionally, P-III portion of BRAVE-AA1 & P-III BRAVE-AA2 study, are currently evaluating baricitinib (2mg/4mg) vs PBO in […]Read More