This week in drug discovery (19-23 August)
News round-up for 19-23 August by DDW Senior Digital Content Editor Diana Spencer.
It’s been a busy week for medical regulatory agencies, with a number of key decisions made on therapies for graft-versus-host-disease, neuroendocrine carcinoma, haemophilia B, lymphoma and non-small cell lung cancer.
The top stories:
FDA approves Niktimvo for chronic graft-versus-host disease
The US Food and Drug Administration (FDA) has approved axatilimab-csfr (Niktimvo), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD).
Neuroendocrine carcinoma drug granted orphan status
Phanes Therapeutics’ PT217 has received orphan drug designation (ODD) for neuroendocrine carcinoma (NEC) from the US Food and Drug Administration (FDA).
First gene therapy for haemophilia B accepted in Scotland
The Scottish Medicines Consortium (SMC) has accepted CSL Behring’s Hemgenix (etranacogene dezaparvovec) for use within NHS Scotland on an interim basis, until full marketing authorisation is granted.
Second lymphoma indication approval for Tepkinly in Europe
AbbVie and Genmab’s Tepkinly (epcoritamab) has been granted conditional marketing authorisation by the European Commission (EC) as a monotherapy for relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.
FDA approves combination therapy for non-small lung cancer
The US Food and Drug Administration (FDA) has approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).