Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA […]readmore
Tags : Accelerated
Shots: The approval follows the P-II study which involves assessing of Trodelvy in 108 adults with TNBC who had previously received a median of three prior systemic therapies in the […]readmore
Shots: The approval is based on P-II study results assessing Sirturo (400 mg first 2wks., 200 mg three times per week) in combination with a background regimen in 15 pediatric […]readmore
Regulatory
Roche’s Polivy (polatuzumab vedotin-piiq) Combination Therapy Receives FDA’s Accelerated Approval
Shots: The accelerated approval is based on P-Ib/II GO29365 study results involves assessing of Polivy + bendamustine + Rituxan (BR)/Gazyva (obinutuzumab) vs BR in patients with r/r follicular lymphoma or […]readmore
Shots: The accelerated approval is based on P-III IMpassion130 study assessing Tecentriq + Abraxane vs PBO + Abraxane in 902 patients with PD-L1+ advanced or mTNBC with no prior therapy […]readmore