Two Lung Cancer Drugs Recommended by EMA

The European Medicines Agency (EMA) recommended eight medicines for approval this month, including two cancer drugs for treating non-small cell lung cancer (NSCLC). 

Repotrectinib for Advanced Cancers

The regulatory body’s Committee for Medicinal Products for Human Use (CHMP) supported granting a conditional marketing authorization for repotrectinib (Augtyro). The drug is intended for adults and adolescents with advanced solid tumors and adults with locally advanced or metastatic NSCLC.

Repotrectinib contains the active substance repotrectinib, a tropomyosin receptor kinase (TRK) inhibitor. It targets cells with constitutive activation of TRK proteins resulting from gene fusions and the proto-oncogene tyrosine-protein kinase ROS (ROS1).

A single arm clinical trial demonstrated that the drug provided a favorable response rate and duration in patients with locally advanced, metastatic solid tumors that display a neurotrophic TRK (NTRK) gene fusion who either were or were not previously treated with an NTRK inhibitor, as well as in patients with ROS1-positive advanced NSCLC.

Common side effects included dizziness, dysgeusia, constipation, paranesthesia, anemia, and dyspnea.

Repotrectinib was recommended as monotherapy for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion and (1) have received a prior NTRK inhibitor or (2) have not received a prior NTRK inhibitor but have limited or exhausted other treatment options.

At its November meeting, the CHMP stipulated that only physicians experienced in anticancer therapies should prescribe repotrectinib, which will be available as 40 mg and 160 mg hard capsules.

The committee recognized that the drug fulfilled an unmet need, but the authorization was granted on the condition that the manufacturer provides additional data at a later date.

Lazertinib: A Combination Therapy

The CHMP also recommended granting marketing authorization for lazertinib (Lazcluze), in combination with amivantamab, for the first-line treatment of NSCLC with activating epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

Lazertinib, an EGFR tyrosine kinase inhibitor, selectively targets EGFR mutations, inhibiting cancer cell growth while minimizing effects on normal cells.

The most common side effects associated with lazertinib are rash, nail toxicity, infusion‑related reaction, hepatotoxicity, stomatitis, venous thromboembolism, paranesthesia, and fatigue.

Available as 80 mg and 240 mg film-coated tablets, lazertinib should be prescribed by physicians experienced in the use of anticancer medicinal products, the committee said.

EMA recommendations for marketing authorizations are subject to ratification by the European Commission.

Peter Russell has been a journalist for 40 years, covering international news, health, medicine, and national politics on radio, TV, and online. He is based in the UK.