Tags : ALL

Clinical Trials

Roche Highlights its Bispecific Antibody Portfolio Across a Range of

Shots: The company presented the new data of its T-cell engaging bispecific Abs, mosunetuzumab, glofitamab and cevostamab at ASH 2020, demonstrating encouraging activity across multiple types of blood cancer Roche divulges that its mosunetuzumab & glofitamab showed promising responses across multiple types of NHL, including R/R FL & DLBCL, reinforcing from the P-I/Ib GO29781 study […]Read More

Biotech

Amgen’s Blincyto (blinatumomab) Receives EU Expanded Indication Approval for Ph-

Shots: The expanded approval is based on P-II BLAST study results assessing Blincyto (15ug/m2/d @4wks.) in patients with 3L + MRD-positive ALL in complete hematologic remission, evaluating its efficacy, safety, and tolerability The study resulted in complete MRD response or no detectable MRD, relapse-free survival, eliminating detectable residual disease with safe and effective results in […]Read More

Regulatory

Servier’s Asparlas (calaspargase pegol-mknl) Receives FDA’s Approval for Acute Lymphoblastic

Shots: The approval is based on study assessing Asparlas (2500 U/m2, IV, q3w) in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL The study resulted in achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL Asparlas (calaspargase pegol-mknl, IV) is an asparagine specific enzyme approved as a […]Read More

Regulatory

Bristol-Myers’ Sprycel (dasatinib) Receives CHMP Recommendation for Philadelphia Chromosome-Positive Acute

Shots: The CHMP (EMA) recommendation is based on P-II CA180-372 (NCT01460160) study assessing Sprycel + CT in pediatric patients with newly diagnosed +ve acute lymphoblastic leukemia (ALL) Sprycel received the US FDA’s and EU’s approval to treat pediatric patients with +ve chronic myeloid leukemia in chronic phase (CML-CP) in Nov, 2017 & July, 2018 respectively Sprycel is a tyrosine kinase inhibitor, […]Read More