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
Shots: The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently approved as a CDx for 20+ therapies The FoundationOne CDx is the tissue-based CGP test approved to detect NTRK1/2/3 fusions across all solid tumor types […]Read More
Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA) If approved, Xolair’s […]Read More
Shots: The approval is based on a P-III study results assessing Eticovo vs the reference product (Enbrel) in 596 patients with rheumatoid arthritis across 70 sites in 10 countries The study resulted in ACR20 (80.8% vs 81.5%) for 52 wks. confirming results of 24 wks. study in (78.1% vs 80.3%) Eticovo (etanercept-ykro) is a biosimilar […]Read More
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
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
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
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