Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

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 results in R/R FL, that showed 51.6% of patients achieved a CR when treated with mosunetuzumab
  • Beyond r/r setting, mosunetuzumab & glofitamab are also being evaluated in 1L DLBCL. Additionally, Roche has presented the data of cevostamab that showed a 53% ORR rate in heavily pre-treated patients with MM

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Financial Times

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Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)

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 and identify patients who may be appropriate for treatment with Vitrakvi
  • The approval of Vitrakvi was based on three studies including LOXO-TRK-14001,  SCOUT, and NAVIGATE studies and is indicated for the treatment of adult and pediatric patients with solid tumors that have NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Clinical OMICs

The post Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib) first appeared on PharmaShots.

Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

Shots:

  • The two partners will jointly enhance the existing platform utilizing One Drop’s know-how and capabilities of the One Drop platform and will co-develop digital health therapies across multiple therapeutic areas               
  • One Drop will receive $98M financing, development fees and commercial milestones while in exchange Bayer will receive royalties on sales. In the future, Bayer may also support the commercialization of the jointly developed digital products
  • The collaboration allows Bayer to accelerate its evolution towards a digital health business with a focus to provide integrated care patient service offerings

Click here ­to­ read full press release/ article | Ref: Bayer | Image: Getty Images

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

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 prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pinterest