FDA approvals in lung cancer treatment

The following chart demonstrates how the pace of FDA approvals for lung cancer treatments has accelerated in recent decades. This rapid development is a result of scientific discoveries and continued progress made possible by funding research. See a list of drugs by decade

Recent FDA approvals

Below is a list of recent FDA approvals for the treatment of lung cancer. In a relatively short time, we’re seeing an exponential increase in treatment approvals!

September 2021

• FDA has approved mobocertinib (Exkivity®) for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Read more

June 2021

• FDA approved sotorasib (Lumakras™) as the first treatment for NSCLC patients whose tumors have the KRAS G12C genetic mutation and who have received at least one prior systemic therapy. Read more

May 2021

• FDA approved amivantamab-vmjw (Rybrevant™) for adults with NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Read more

March 2021

• FDA approved lorlatinib (Lorbrena®) targeted therapy drug now for the first-line treatment of NSCLC patients with the ALK mutation. Read more

February 2021

• FDA approved cemiplimab-rwlc (Libtayo®) immunotherapy drug for first-line treatment for NSCLC patients with high PD-L1 expression and who are not eligible for surgery or chemoradiation. Read more
• FDA approved trilaciclib (Cosela™), a drug that reduces chemotherapy-induced bone marrow suppression, for SCLC patients. Read more
• FDA approved tepotinib (Tepmetko®) for the treatment of metastatic non-small cell lung cancer (NSCLC) patients who have the MET exon 14 skipping alterations. Read more

December 2020

• FDA approved osimertinib (Tagrisso) for adjuvant therapy for NSCLC patients who have undergone resection and have tumors positive for either EGFR exon 19 or exon 21 L858R. Read more

October 2020

• FDA approved FoundationOne CDx companion diagnostic test to help identify NTRK+ solid tumor patients eligible for larotrectinib and to help identify ALK+ patients eligible for alectinib. Read more 
• FDA approved “cobas EGFR mutation test v2” to identify NSCLC patients eligible for any of the EGFR inhibitor therapies, including those used to treat EGFR exon 19 and L858R deletions, as well as any EGFR therapies to come in the future. Read more

September 2020

• FDA approved pralsetinib (Gavreto) for people with metastatic non-small-cell lung cancer (NSCLC) who have the MET exon 14 mutation. Read more

August 2020

• FDA approved Guardant360 CDx assay, a liquid biopsy (blood test) that also uses next-generation sequencing (NGS) technology to identify patients with the EGFR mutation. Read more

June 2020

• FDA approved lurbinectedin (Zepzelca) for the second-line treatment of patients with metastatic SCLC. Read more

May 2020

• FDA approved combination ramucirumab and erlotinib for first-line treatment of NSCLC patients with the EGFR exon 19 or exon 21 mutations. Read More
• FDA approved combination nivolumab (Opdivo) and ipilimumab (Yervoy) for the first-line treatment of patients with PD-L1+ metastatic NSCLC. This combination can also be used as a first-line treatment in conjunction with chemotherapy for metastatic NSCLC. Read more
• FDA approved brigatinib (Alunbrig) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) patients with the ALK mutation. Read More
• FDA approved atezolizumab (Tecentriq) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) patients who have high PD-L1 expression. In conjunction with this approval, the FDA approved the diagnostic test Ventana PD-L1 assay. Read More
• FDA approved capmatinib (Tabrecta) as a treatment for metastatic non-small cell lung cancer (NSCLC) patients who have the MET exon 14 mutation. In conjunction with this approval, the FDA approved the diagnostic test FoundationOne CDx assay. Read More
• FDA approved selpercatinib (Retevmo) as a treatment for non-small cell lung cancer (NSCLC) patients or thyroid cancer patients who have the RET mutation. Read More

March 2020

• FDA approved durvalumab (Imfinzi) in combination with chemotherapy as a first line treatment for extensive stage small cell lung cancer (SCLC). Read More

February 2020

• FDA approved pemetrexed (Pemfexy) injectable chemotherapy for treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC). Read More

Approved drugs by decade