MHRA authorises Lilly’s RET inhibitor Retsevmo
11th March 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Eli Lilly’s Retsevmo a conditional marketing authorisation for the treatment of RET fusion-positive advanced lung cancer and thyroid cancer.
In particular, the authorisation includes Restevmo (selpercatinib) as monotherapy treatment for adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
It also includes the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy after prior treatment with sorafenib/lenvatinib, and also for adults and adolescents aged 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment.
Bumper December meeting sees CHMP recommend 15 new medicines
14th December 2020
The European Medicines Agency’s (EMA) committee for Medicinal Products for Human Use (CHMP) recommended 15 new medicines for approval in its final meeting of the year.
First to score a recommendation was AstraZeneca/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer, following an accelerated review of the anti-HER2 therapy.
The CHMP also recommended Dynavax’s Heplisav (hepatitis B surface antigen) for active immunisation against hepatitis B virus infection and ViiV Healthcare’s Rukobia (fostemsavir) for the treatment of multidrug resistant HIV-1 infection.
Up next, the CHMP adopted a positive opinion for Bristol Myers Squibb’s Inrebic (fedratinib) for the treatment of primary myelofibrosis and myelofibrosis secondary to polycythaemia vera, as well as essential thrombocythaemia.