CHMP meeting highlights: April 2024

The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines.

A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A.

Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B.

Recommendations for new cancer treatments

The committee also adopted a positive opinion for Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer in adults.

If approved, fruquintinib could provide a new oral, chemotherapy-free option as the first and only selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR) receptors approved in the EU for this disease, according to Takeda.

The CHMP’s positive opinion is based on results from the Phase III FRESCO-2 trial. 

Additionally, the committee recommended AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) to treat locally advanced or metastatic breast cancer with one or more specific mutations.

“With this combination demonstrating a fifty per cent reduction in disease progression or death in patients with tumours harbouring PIK3CA, AKT1, or PTEN-alterations in the [Phase III] CAPItello-291 trial, this positive recommendation marks an important step in providing a much-needed new treatment option for approximately half of patients in this setting with these specific tumour biomarkers,” noted Dr Mafalda Oliveira, PhD, Senior Consultant at the Department of Medical Oncology, Vall d’Hebron University Hospital, and Senior Clinical Investigator of the Vall d’Hebron Institute of Oncology’s (VHIO) Breast Cancer Group in Barcelona, Spain.

Other positive opinions included for Jeraygo (aprocitentan), as a treatment for resistant hypertension, and Obgemsa (vibegron) for adults with overactive bladder syndrome.

CHMP biosimilar recommendations

A positive opinion for Tofidence (tocilizumab) was adopted by the committee, indicated for rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

The committee also recommended the biosimilar medicine Wezenla (ustekinumab) to treat of plaque psoriasis. This covers paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.

Generic medicine Eribulin Baxter (eribulin) was also granted a positive opinion by the committee, to treat breast cancer and liposarcoma.

Further recommendations

Finally, the CHMP recommended extending indications for six medicines currently approved in the EU: Alecensa, Opdivo, Rozlytrek, Rybrevant, Sirturo and Triumeq.

Moreover, the CHMP stated that it recommended new contraindications for co-administration of Reyataz (Atazanavir) with encorafenib and ivosidenib, and with carbamazepine, phenobarbital, and phenytoin.

CHMP meeting highlights: March 2024