Shots: The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with at least 2L of systemic […]readmore
Tags : Follicular Lymphoma
Shots: The approvals is based on P-II UNITY-NHL trial involves assessing Ukoniq (800 mg, qd) in 69 patients with MZL who has received at least 1 prior anti-CD20 based regimen […]readmore
Shots: The data includes P-l/lla study involves assessing BI-1206 + rituximab in patients with FL, MZL and MCL who have r/r to rituximab. The study demonstrated at BI-1206 is generating […]readmore
Shots: The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally At the interim analysis, […]readmore
Shots: The US FDA has granted BTD to the Roche’s mosunetuzumab for the treatment of adult patients with r/r FL, prior treated with at least two systemic therapies The BT […]readmore
Regulatory
Novartis’ Kymriah (tisagenlecleucel) Receives the US FDA’s Regenerative Medicine Advanced
Shots: Shots: The US FDA has granted RMAT designation to Novartis’ Kymriah (tisagenlecleucel) to treat patients with r/r FL. The designation is based on P-II ELARA study evaluating the efficacy […]readmore
Shots: The US FDA has accepted NDA for the accelerated approval of Tazverik for patients with relapsed/refractory FL prior treated with 2L+ systemic therapies The US FDA has granted PR […]readmore
Shots: CPSC has dosed its first patients in a Chinese bridging study assessing Copiktra in patients with r/r FL In Sept’2018, the companies signed an exclusive licensing agreement which allows […]readmore
Shots: The approval is based on P-III AUGUMENT study involves assessing of Revlimid + Rituximab (R2) vs rituximab +PBO in patients with previously treated follicular lymphoma (FL) or marginal zone […]readmore
Shots: The P-III study involves assessing of Truxima vs Rituxan in 140 patients with AFL for 40mos. across India, Japan, Russia, and the EU, including Germany and Spain The P-III […]readmore