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BioBlast® w/e 27 May 22 : Prestige’s trastuzumab rejected by CHMP; Additional EU indications for Merck’s Keytruda; Jury trial set in BMS/AstraZeneca patent infringement suit re durvalumab; First patients dosed in Biond Biologics trials for BND-22 (SAR444881); FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim).. and more

by | May 30, 2022

20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®)
Prestige’s trastuzumab rejected by CHMP

The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab biosimilars Tuznue® and Hervelous®.  The CHMP stated that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing, and considered that ”the studies presented did not provide enough evidence to show that the commercially produced medicine will be biosimilar to the reference medicine”.  Korea Biomedical Review reported that Singapore based, Kosdaq-listed Prestige Biopharma will appeal the decision.

20 May 22 | EU | Merck | Keytruda®, pembrolizumab
Additional EU indications for Merck’s Keytruda®

Merck announced that it has received a positive opinion from the CHMP for its  anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection.  CHMP additionally recommended expansion of the Keytruda indications into advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients (12 years and older).

Days later Merck announced that the EC has approved Keytruda® (pembrolizumab) with chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.  Merck says this is the fifth approval for Keytruda in a breast or gynecologic cancer in the EU in less than a year.

23 May 22 | US | BMS, AstraZeneca | Imfinzi®, durvalumab
Jury trial set for April 2024 in BMS/AstraZeneca patent infringement suit re durvalumab

The US District Court of Delaware has set down BMS’ patent infringement case against AstraZeneca regarding Imfinzi® (durvalumab) as a jury trial in April 2024.  BMS filed a complaint against AstraZeneca in March 2022, alleging that AstraZeneca’s Imfinzi® (durvalumab) infringes eight of its patents relating to anti-PD-L1 antibodies.

23 May 22 | Biond Biologics (Merck) | BND-22 (SAR444881) with pembrolizumab (Keytruda®) or cetuximab (Erbitux®)
First patients dosed in Biond Biologics trials for BND-22 (SAR444881) with pembrolizumab or cetuximab

Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US.  BND-22 is being developed under an exclusive world wide licence with Sanofi.

24 May 22 | UK | Roche/Genentech | Vabysmo®, faricimab
UK NICE recommends Vabysmo® (faricimab) for AMD and DMO

The UK’s NICE published final draft guidance recommending Vabysmo® (faricimab) for the treatment of adult patients with wet age-related macular degeneration (AMD) or diabetic macular oedema (DMO).

24 May 22 | US | Alpine Immune Sciences (Merck) | davoceticept, pembrolizumab (Keytruda®)
FDA lifts partial clinical hold on NEON-2 pembrolizumab trial

Alpine Immune Sciences announced that the FDA has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (first-in-class conditional CD28 costimulator and dual checkpoint inhibitor) in combination with pembrolizumab in adults with advanced malignancies.   The partial clinical hold (now lifted) was implemented in March 2022 after a grade 5 serious adverse event leading to a patient’s death occurred.

27 May 22 | US | Amneal (Amgen) | Fylnetra™, pegfilgrastim (Neulasta®)
FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim)

Amneal Pharmaceuticals announced that the FDA has approved its ABLA for Fylnetra™ (biosimilar pegfilgrastim).  Fylnetra™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.  This is Amneal’s third biosimilar approved in the USA (following its filgrastim and bevacizumab biosimilars), which was developed in collaboration with Chicago based Kashiv Biosciences.

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