At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication extensions for five.
The new biologics are AbbVie’s antibody drug conjugate Elahere® (mirvetusimab soravtansine) for treatment of adults with ovarian, fallopian tube or primary peritoneal cancer (which received FDA approval in March 2024); Pfizer’s Hympavzi® (marstacimab) for bleeding episodes in patients aged 12 years and older with sever haemophilia A or B; and Henlius/Intas’ Hetronifly® (serplulimab) for first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC).
Hetronifly® (serplulimab) will reportedly be commercialised by Intas through its subsidiary, Accord Healthcare, across more than 30 countries in Europe. Serplulimab has previously been launched as HANSIZHUANG in China, Indonesia, Cambodia and Thailand.
The five recommended indication expansions for biologics are:
- Janssen’s Darzalex® (daratumumab), in combination with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant;
- Sanofi’s Dupixent® (dupilumab) for eosinophilic esophagitis in adults, adolescents and children aged 1 year and older who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy;
- AstraZeneca’s Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis;
- Novo Nordisk’s Esperoct® (turoctocog alfa pegol) for treatment and prophylaxis of bleeding in all age groups with haemophilia A (congenital factor VIII deficiency); and
- MSD’s Keytruda® (pembrolizumab) for two cancer indications: (i) in combination with carboplatin and paclitaxel, followed by Keytruda® as a single agent, for first-line treatment of adults with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy; and (ii) in combination with chemoradiotherapy (CRT) for FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.
In addition, two aflibercept biosimilars received positive opinions at CHMP’s September 2024 meeting, as reported here.