Avapritinib’s conditional marketing authorization granted by EMA

The EMA’s (European Medicines Agency) Committee for Medicinal Products for Human Use adopted a positive view, advocating the granting of a conditional marketing authorization for avapritinib on 23 July 2020 and this medicinal product will be available as film-coated 100 mg, 200 mg, and 300 mg tablets.

It is intended for managing adult patients having unresectable or metastatic GIST (gastrointestinal stromal tumors) harboring the PDGFR (platelet-derived growth factor receptor) alpha D842V mutation. It is devised to selectively suppress oncogenic KIT and PDGFR alpha mutants by effectively targeting the active conformation of the kinase.

In patients with GIST harboring the PDGFR alpha D842V mutation, Avapritinib has the power to yield durable responses. Fatigue, nausea, anemia, face oedema, periorbital oedema, hyperbilirubinemia, vomiting, diarrhea, oedema peripheral, increased lacrimation, memory impairment, and decreased appetite are the foremost adverse effects witnessed in ≥20% of patients.

For managing adult patients with unresectable or metastatic GIST harboring the PDGFR alpha D842V mutation, Avapritinib is indicated as monotherapy. It is suggested that Avapritinib should be prescribed by physicians experienced in managing cancer. In the summary of product characteristics, detailed recommendations for the utilization of this product will be elucidated.

After the grant of marketing authorization by the European Commission, it will be issued in the European public assessment report and made available in all official European Union languages.

Summaries of positive opinion will normally be issued 67 days from the adoption of the opinion and are issued without prejudice to the decision of the European Commission.

The marketing authorization holder will offer comprehensive clinical data at a later stage. During its development, this product was designated as an orphan medicine. EMA will now evaluate the available information to assess whether the orphan designation can be maintained.