It was a particularly eventful year in the non–small cell lung cancer (NSCLC) field with 11 FDA approvals, but that wasn't all in the lung cancer space. The regulatory body greenlit 2 agents for patients with small cell lung cancer (SCLC) and 1 regimen for those with malignant pleural mesothelioma.

Drugs that made a notable splash throughout the year were amivantamab-vmjw (Rybrevant) which earned 3 FDA approvals in NSCLC, and durvalumab (Imfinzi) and osimertinib (Tagrisso) which snagged 2 indications each in the lung cancer field, further expanding the treatment armamentarium.

Pembrolizumab (Keytruda) and nivolumab (Opdivo) also received 3 indications each from the FDA in 2024, with each drug receiving one of them in lung cancer.

Keep reading to see the full list of lung cancer approvals from 2024 and insights from experts who sat down with us at OncLive® throughout the year to discuss their significance.

Tepotinib (Tepmetko)

Approval type: Regular
Indication: Adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations
Month: February
To read more, visit: bit.ly/3ZWmzeb

Osimertinib plus platinum-based chemotherapy

Approval type: Regular
Indication: Patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
Month: February
To read more, visit: bit.ly/4gEmcu6

"[There are] several different types of benefits of the combination over osimertinib alone. We’re excited to see this move forward and have the combination available to treat our patients…. [As] it’s a fairly well-tolerated medicine, it lends itself to study combinations like chemotherapy in combination with osimertinib.”

Pasi A. Jänne, MD, PhD
Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts

Amivantamab plus carboplatin and pemetrexed

Approval type: Regular
Indication: Frontline treatment of patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test
Month: March
To read more, visit: bit.ly/49Jtxq1

Alectinib (Alecensa)

Approval type: Regular
Indication: Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC, as detected by an FDA-approved test
Month: April
To read more, visit: bit.ly/4gh2HYR

Amivantamab plus lazertinib (Lazcluze)

Approval type: Regular
Indication: First-line treatment of locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test
Month: August
To read more, visit: bit.ly/4gh2HYR

"Amivantamab is one of the first therapeutic options I’ve seen that has shown broad activity across all EGFR mutations…. Now we need to work on managing and mitigating toxicities. We also need to think about the next generation of inhibitors, building upon therapies we have.”

Joshua K. Sabari, MD
NYU Langone Health Perlmutter Cancer Center, New York, New York

Perioperative durvalumab plus chemotherapy

Approval type: Regular
Indication: Durvalumab in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment, for adult patients with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements
Month: August
To read more, visit: bit.ly/4gl9Jfi

Amivantamab plus carboplatin and pemetrexed

Approval type: Regular
Indication: Adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI
Month: September
To read more, visit: bit.ly/4gEmYHw

Osimertinib

Approval type: Regular
Indication: Adult patients with locally advanced, unresectable stage III NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
Month: September

To read more, visit: bit.ly/4gh2HYR

Perioperative nivolumab plus chemotherapy

Approval type: Regular
Indication: Nivolumab with platinum-doublet
chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements
Month: October
To read more, visit: bit.ly/401eGmL

"We still have to define which patients need perioperative therapy vs which are sufficiently treated with a pure neoadjuvant regimen, but [this regimen] gives both patients and oncologists the option to escalate treatment if they feel the need to do so after neoadjuvant therapy and surgery.”

Jonathan Spicer, MD, PhD, FRCSC
McGill University and Montreal General Hospital, Quebec, Canada

Zenocutuzumab-zbco (Bizengri)

Approval type: Accelerated
Indication: Adults with advanced, unresectable, or metastatic NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy
Month: December
To read more, visit: bit.ly/3VJAv8T

Ensartinib (Ensacove)

Approval type: Regular
Indication: Adult patients with ALK-positive locally advanced or metastatic NSCLC who did not previously receive an ALK inhibitor
Month: December
To read more, visit: bit.ly/3DFlKha

Tarlatamab-dlle (Imdelltra)

Approval type: Accelerated
Indication: Extensive-stage SCLC with disease progression on or after platinum-based chemotherapy
Month: May
To read more, visit: bit.ly/3OZY1dW

Pembrolizumab plus pemetrexed and platinum chemotherapy

Approval type: Regular
Indication: Frontline treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
Month: September
To read more, visit: bit.ly/3VDk9OT

Durvalumab

Approval type: Regular
Indication: Adults with limited-stage SCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
Month: December
To read more, visit: bit.ly/4gGMdt8

Reference

1. Advancing health through innovation: New drug therapy approvals 2024. FDA. Accessed February 4, 2025. bit.ly/3WKqf0s