Shots: The approval is based on P-lll VIALE-A & VIALE-C studies and updated data from the P-Ib M14-358 and the P-I/II M14-387 studies. The P-III studies involve assessing of Venclexta (400mg & 600mg, qd) + azacitidine & LDAC vs PBO + azacitidine & LDAC in 431 & 211 people with previously untreated AML who are […]Read More
Shots: Kite enters into a two-year research collaboration and license agreement with HiFiBiO to discover novel targets and Abs against AML HiFiBiO will receive an up front and will utilize its technology platform to identify novel AML targets and anti-AML specific Abs to support Kite’s development of cell therapies Kite to get an exclusive option […]Read More
Shots: The approval is based on P-III QUAZAR AML-001 study assessing Onureg (300 mg, PO) vs PBO for 14 days of a 28-day cycle + BSC in a ratio (1:1) in 472 patients aged ≥55yrs. with AML and had achieved CR or Cri following intensive induction CT and cannot proceed intensive curative therapy including HSCT The P-III […]Read More
Shots: The approval is based on P-III ADMIRAL study assessing Xospata (120mg) vs salvage CT in 371 patients in a ratio (2:1) with r/r AML and FLT3 mutation in bone marrow or in whole blood The P-III ADMIRAL study results demonstrated longer OS (9.3 vs 5.6mos.), rate of survival @1yr. (37% vs 17%) Xospata is […]Read More
Shots: The approval is based on P-III ADMIRAL study assessing Gilteritinib as monothx. vs salvage CT In patients with relapsed or refractory FLT3mut+ AML. The approval follows EMA’s accelerated assessment and ODD which reduced the timeframe for approval The P-III ADMIRAL study resulted in longer OS i.e, mOS (9.3 vs 5.6mos.); rates of one-year survival […]Read More
Shots: The P-III QUAZAR AML-001 study involves assessing of CC-486 (300mg) as maintenance therapy vs PBO + SoC in 472 patients in a ratio (1:1) with AML who achieved first CR with incomplete blood count recovery (CRi) with induction chemotherapy (with/out consolidation) The P-III QUAZAR AML-001 study resulted in meeting its 1EPs & 2EPs i.e, […]Read More
Shots: Cantex to receive $30M up front, $587.5M regulatory and commercial milestones and royalties starting at 10%. Chimerix to get exclusive WW rights to develop and commercialize Cantex’s CX-01 and has also issued $10M shares in its common stock to Cantex The focus of the agreement is to accelerate and advance the development of CX-01 […]Read More
Shots: Macrogenic plans for the onset of a trial evaluating flotetuzumab + MGA012 to broaden the DOR of flotetuzumab in AML patients. Macrogenic will regain WW rights to develop and commercialize flotetuzumab with the termination of the license agreement with Laboratoires Servier signed on Sept’2012, which will be effective on Jan 15, 2020 MacroGenics has […]Read More
Shots: Astellas partners with Concerto HealthAI to uitilize Concerto’s RWD in order to track the response in patients with FLT3 mutation-positive r/r AML The companies will utilize ASCO’s CancerLinQ Discovery database of de-identified cancer patient records to improve understanding of responses in patients, AML treatment patterns, disease progression and opportunities for improved QoL The […]Read More
Shots: The ODD designation is based on the study results assessing devimistat + high dose cytarabine & mitoxantrone and devimistat + folfirinox in patients with r/r AML and mPC respectively R/R AML study results: CR + Cri (52%); mOS (12.4 mos.), mPC study results: ORR (61%); mOS (19.9 mos.); mPFS (9.9 mos.), with safe […]Read More
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