Two Lung Cancer Drugs Recommended by EMA

You May Be Interested In:Trump threatens tariffs on Apple iPhones and EU products


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

Augtyro for Advanced Cancers

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

Augtyro 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.

Augtyro 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 Augtyro, 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.

Lazcluze: A Combination Therapy

The CHMP also recommended granting marketing authorization for Lazcluze (lazertinib) 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.

Lazcluze, 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 Lazcluze are rash, nail toxicity, infusion‑related reaction, hepatotoxicity, stomatitis, venous thromboembolism, paranesthesia, and fatigue.

Available as 80 mg and 240 mg film-coated tablets, Lazcluze 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. 

share Paylaş facebook pinterest whatsapp x print

Similar Content

Strive Health improves key KPIs with homegrown machine learning
Strive Health improves key KPIs with homegrown machine learning
A white cross stands in green grass, adorned with candles and other memorial objects. Beside the cross is a sign that reads, "Pray for Parkland."
Little Tracking, Wide Variability Permeate the Teams Tasked With Stopping School Shootings – KFF Health News
Allergy medications: Know your options
Fingernail do’s and don’ts
Canadian Scientists Keep Watchful Eye on H5N1 Human Case
Canadian Scientists Keep Watchful Eye on H5N1 Human Case
How Mayo Clinic is using real-world data to advance precision medicine
How Mayo Clinic is using real-world data to advance precision medicine
Google sets mandatory MFA deadline for all cloud accounts
Google sets mandatory MFA deadline for all cloud accounts
Frontline Reports | © 2024 | News