Category: acute myeloid leukemia

AbbVie’s Venclyxto Receives the EC’s Approval for Patients with Newly Diagnosed Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy

AbbVie, acute myeloid leukemia, AML, approval, azacytidine, Decitabine, EC, regulatory, Venclyxto / May 26, 2021 May 26, 2021

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 + …

AbbVie’s Venclyxto Receives the EC’s Approval for Patients with Newly Diagnosed Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy Read More »

Daiichi Sankyo Reports First patient Dosing in P- I/II Trial of DS-1594 to Treat Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

acute myeloid leukemia, and Acute Lymphoblastic Leukemia, Clinical Trials, Daiichi Sankyo, Dosing, DS-1594, First, P- I/II Trial, Patient, reports, Treat / April 8, 2021 April 8, 2021

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 …

Daiichi Sankyo Reports First patient Dosing in P- I/II Trial of DS-1594 to Treat Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia Read More »

AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

AbbVie, acute myeloid leukemia, receives, regulatory, US FDA Approval, Venclexta, venetoclax / October 19, 2020 October 19, 2020

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 …

AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia Read More »

Kronos Bio raises $155M in private financing to advance lead leukemia drug into registration study next year

acute myeloid leukemia, BioPharma, BlackRock, California, Casdin Partners, Commodore Capital, Daily, EcoR1 Capital, Entospletinib, Fidelity Management and Research Company, Gilead Sciences, Kronos Bio, San Mateo, Startups, Surveyor Capital, SYK inhibitors, SYN, T. Rowe Price Associates, Top Story, Woodline Partners / August 24, 2020 August 24, 2020

The company has raised $148 million so far and plans to raise the remaining $7 million by next month. Its lead candidate is entospletinib, a SYK inhibitor acquired as part of a deal with Gilead Sciences last month, under development for patients with biomarker-defined acute myeloid leukemia.