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, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the […]Read More
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 designation is based on P-I/Ib GO29781 study assessing mosunetuzumab in R/R non-Hodgkin lymphoma. The safety profile of the therapy was consistent with its mechanism of […]Read More
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 and safety of tisagenlecleucel in adult patients with r/r FL The RMAT designation supports the advancement of Kymriah and reflects the unmet need for patients […]Read More
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 and designated its NDA as sNDA. The sNDA is based on P-II study that demonstrated clinical benefits and was well tolerated in FL patients with […]Read More
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 CPSC to develop & commercialize Verastem’ Copiktra for all oncology indications in China. The study is expected to serve as a bridging study based on […]Read More
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 lymphoma (MZL) The study resulted improvement in 1EP mPFS (39.4 mos. vs 13.8 mos.) with median follow up 29.2 months. Additionally, the safety and efficacy […]Read More
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 study results: @4yrs. OS (88% vs 93.4%); PFS (60.9% vs 54.7%); TTP (64.2% vs 60.9%), presented at ASH2019 Celltrion has launched Truxima in the US […]Read More
Shots: The approval is based on P-III AUGMENT study results assessing Revlimid + Rituximab (R2) vs rituximab + PBO in patients with previously treated FL & MZL, following its PR designation The P-III AUGMENT study results: mPFS (39.4 vs 14.1 mos.); improvement in OS; median follow-up time (28.3 mos.) Revlimid is a thalidomide analog and […]Read More
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