The CHMP recommended the granting of a conditional marketing authorization for pralsetinib (Gavreto) for the treatment of non–small cell lung cancer (NSCLC).
Specifically, pralsetinib is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced NSCLC not previously treated with a RET inhibitor.
Available as 100 mg capsules, pralsetinib is a RET-receptor tyrosine kinase inhibitor, targeting oncogenic RET fusion proteins (KIF5B-RET and CCDC6-RET).
Pralsetinib’s benefits are its objective response rate and response duration in patients with RET-fusion positive NSCLC, as observed in a pivotal phase 1/2, open-label, multi-cohort, single-arm study.
The most common side effects are anemia, increased aspartate aminotransferase, neutropenia, constipation, musculoskeletal pain, fatigue, leukopenia, increased alanine aminotransferase, and hypertension.
CHMP also recommended ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib (Gleevec).
Available as 50 mg tablets, ripretinib is a protein kinase inhibitor designed to selectively block the oncogenic KIT and PDGFRA kinases by inhibiting their active conformation.
Ripretinib improved progression-free survival in patients with GIST.
The most common side effects are fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome, weight loss, and vomiting.
The third drug recommended for approval was zanubrutinib (Brukinsa) for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or who are to receive the drug as first-line treatment (and are unsuitable for chemo-immunotherapy).
Available as 80 mg capsules, zanubrutinib is a Bruton’s tyrosine kinase inhibitor that blocks the activity of BTK, inactivating the pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
Zanubrutinib has demonstrated a clinically meaningful rate of very good partial response and/or complete response.
The most common side effects are neutropenia, thrombocytopenia, upper respiratory tract infection, hemorrhage/hematoma, rash, bruising, anemia, musculoskeletal pain, diarrhea, pneumonia, and cough.
Two new indications for already marketed drugs
CHMP also recommended an extension of the indications for two immunotherapies.
Pembrolizumab (Keytruda) will now also have an indication for use in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumors express PD-L1 with a CPS greater than or equal to 10 and who have not received prior chemotherapy for metastatic disease
Nivolumab (Opdivo) received an extension of indication to include use, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, in the firstline treatment of adult patients with HER2 negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) greater than or equal to 5.
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