RECENT NEW APPROVALS IN LUNG CANCER

Adjunct information to update this week's lecture in THE BIOLOGY OF CANCER

There have been several recent notable FDA approvals for new treatments in lung cancer.

1. Enhertu for advanced non-small cell lung cancer (NSCLC) with a HER2 mutation. This approval is significant for patients with this specific mutation, offering a new treatment option that has shown efficacy in shrinking tumors and controlling cancer for a median of 9 months. Enhertu, an antibody-drug conjugate, targets the HER2 protein on the surface of lung cancer cells, introducing a potent chemotherapy agent directly into the cancer cells

Enhertu Approved for Lung Cancer - NCI

2. Tepotinib (Tepmetko) received traditional approval in February 2024 for adults with metastatic NSCLC harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. This approval, transitioning from an accelerated approval based on earlier data, was supported by extended follow-up and additional patient outcomes, confirming its efficacy in treating this specific genetic alteration in lung cancer.

FDA approves tepotinib for metastatic non-small cell lung cancer | FDA

3. Encorafenib with binimetini for metastatic NSCLC with a BRAF V600E mutation. Approved in October 2023, this combination therapy is aimed at adult patients with this specific genetic mutation, offering a targeted treatment approach that could potentially improve outcomes for this subgroup of lung cancer patients.

Oncology (Cancer) / Hematologic Malignancies Approval Notifications | FDA

4. Amivantamab-vmjw

On March 1, 2024, the FDA approved Amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This was based on a significant improvement in progression-free survival compared to carboplatin and pemetrexed alone in a study. This approval also transitions a previous accelerated approval to traditional approval for patients whose disease progressed after platinum-based chemotherapy.

5. FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer | FDA

On February 16, 2024, the FDA approved osimertinib (Tagrisso) in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) exhibiting EGFR exon 19 deletions or exon 21 L858R mutations. This approval was based on a significant improvement in progression-free survival observed in the FLAURA 2 trial compared to osimertinib monotherapy. The study highlighted osimertinib's role in extending the time patients lived without their cancer progressing when used alongside chemotherapy.

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