BioBlast® w/e 15 July 2022: Alvotech board expansion, [vic-]trastuzumab duocarmazine BLA accepted, second Zylonta® + rituximab DLBCL trials, Polpharma natalizumab MAA and eight-year Perjeta® data

by , | Jul 18, 2022

11 Jul 22 | Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL

Overland ADCT BioPharma announced the dosing of the first patient in China in its second phase III clinical trials regarding Zynlonta® (loncastuximab tesirine-lpyl, a CD19-directed antibody drug conjugate), this time with rituximab  in second-line or later, transplant ineligible patients with diffuse large B-cell lymphoma (DLBCL).  The studies are intended to support sBLA filings in US and the PRC.  Zynlonta® was granted accelerated approval by the FDA in April 2021.

12 Jul 22 | FDA accepts Byondis B.V.’s BLA for [vic-] trastuzumab duocarmazine

Byondis B.V. announced that the FDA has accepted its BLA for [vic-] trastuzumab duocarmazine (SYD985), a HER2-directed antibody-drug conjugate, for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), with a PDUFA action date of 12 May 2023.  This is Byondis’ first regulatory submission for SYD985 which is its lead program.  In January 2018, the FDA granted fast track designation for SYD985, based on promising Phase I data for pretreated last-line HER2-positive MBC patients.

14 Jul 22 | Alvotech expands Board of Directors

Alvotech announced the expansion of its board of directors as part of its transition from private to publicly traded company in June 2022.  Alvotech has welcomed four new board members, Lisa Graver, Arni Hardarson, Linda McGoldrick and Ann Merchant, joining existing board members Robert Wessman (founder and Executive Chairman), Richard Davies, Tomas Ekman and Faysal Kalmoua.

15 Jul 22 | EMA accepts MAA for Polpharma’s biosimilar natalizumab

Polpharma Biologics announced that the EMA has accepted its MAA for its biosimilar natalizumab for highly active relapsing-remitting multiple sclerosis with the same dosing, presentation and indication as Tysabri®.  Polpharma granted Sandoz commercialisation rights to Polpharma’s biosimilar under a global agreement announced in September 2019.

14 Jul 22 | Roche publishes eight-year data on Perjeta® based regimen for breast cancer

Roche reported that eight-year data from its Ph III trials of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy in HER2-positive early breast cancer demonstrates continued benefit of the combination in comparison to trastuzumab and chemotherapy alone.  Roche reported a 28% reduction in the risk of recurrence or death in patients with lymph node-positive disease, and a safety profile consistent with previous studies.

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