Shots: The EC approval is based on a P-III QUAZAR AML-001 study assessing Onureg (300mg, qd) vs PBO + BSC for 14days of a 28-day cycle in patients aged ≥55yrs. with AML who achieved CR or with CRi following induction therapy with/out consolidation treatment and who are not candidates for, including those who choose not […]Read More
Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed AML who were ineligible for intensive CT and demonstrated OS (14.7mos. vs 9.6mos.), CCCR (66.4% vs 28.3%), CR (36.7% vs 17.9%) The P-Ib M14-358 trial involves assessing in Venclyxto + […]Read More
Shots: MD Anderson will sponsor and lead P-I/II study to assess DS-1594 as monothx. and in combination regimens for patients with r/r AML and ALL The 1EPs of the P-I part of the study is to determine the maximum tolerated dose and RP2D of DS-1594 in ~54 patients with AML or ALL regardless of mutation […]Read More
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
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