The pace of FDA approvals for lung cancer treatments has been accelerating in recent decades. This rapid development exemplifies the discoveries and continued progress made by LCRF and other investigators around the world.
Below is a list of recent FDA approvals for the treatment of lung cancer. In 2020, we saw an exponential increase in treatment approvals and expect this trend to continue. Make sure to check back regularly for updates.
September 2021
- FDA has approved mobocertinib 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
December 2019
- FDA approved atezolizumab (Tecentriq) in combination with chemotherapy (nab-paclitaxel and carboplatin) as a first line treatment of non-squamous non-small cell lung cancer (NSCLC) that has metastasized and is not EGFR or ALK+. Read More
August 2019
- FDA approved a targeted therapy entrectinib (Rozlytrek) for either NTRK+ solid tumors or ROS1+ patients with metastatic non-small cell lung cancer (NSCLC). Read More
June 2019
- FDA approved pembrolizumab (Keytruda), an immunotherapy treatment that can be used for treatment of patients with metastatic small cell lung cancer (SCLC) when chemotherapy and one other treatment is no longer working for them. Read More
UPDATE AS OF MARCH 2021: Merck has voluntarily withdrawn this approval based on the Phase III results of the KEYNOTE-604 clinical trial. Read More
April 2019
- FDA approved pembrolizumab (Keytruda), an immunotherapy treatment that can be used for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC).
March 2019
- FDA approved atezolizumab (Tecentriq) in combination with chemotherapy for first line treatment of extensive stage SCLC. Read More
December 2018
- FDA approved atezolizumab (Tecentriq) in combination with chemotherapy (bevacizumab, paclitaxel and carboplatin) as a first line treatment of non-squamous non-small cell lung cancer (NSCLC) that has metastasized and is not EGFR or ALK+. Read More
November 2018
- FDA approved lorlatinib (Lorbrena) as a second or third line treatment for patients with ALK+ metastatic non-small cell lung cancer (NSCLC). Read More
- FDA approved larotrectinib (Vitrakvi), a targeted therapy used as a subsequent treatment for patients with NTRK+ solid tumors* whose cancer has progressed following treatment and/or surgery is not an option. Read more
*Treatment indication is not exclusive to lung cancer, but to all solid cancer tumors that have the NTRK genetic mutation.
October 2018
- FDA approved pembrolizumab (Keytruda) in combination with chemotherapy as a first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). Read More
September 2018
- FDA approved dacomitinib (Vizimpro) as a first-line treatment for patients with EFGR+ metastatic non-small cell lung cancer (NSCLC). Read More
August 2018
- FDA approved pembrolizumab (Keytruda) in combination with chemotherapy as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC). Read More
- FDA approved nivolumab (Opdivo) as a third-line treatment for patients with metastatic small cell lung cancer (SCLC). Read More
April 2018
- FDA approved osimertinib (Tagrisso) as a first-line treatment for EGFR+ patients with metastatic non-small cell lung cancer (NSCLC). Read More
February 2018
- FDA approved durvalumab (Imfinzi) after chemoradiation treatment for patients with unresectable stage III non-small cell lung cancer (NSCLC). Read More
January 2018
- FDA approved afatinib (Gilotrif) for a broadened indication in first-line treatment of EGFR+ patients with metastatic non-small cell lung cancer (NSCLC). Read More
FDA drug approval timeline
1940s
Mechlorethamine Hydrochloride
1970s
Methotrexate
Doxorubicin Hydrochloride
1980s
Cisplatin
1995-2005
Etoposide
Gemcitabine Hydrochloride
Docetaxel
Carboplatin
Gefitinib
Erlotinib
2006-2015
Bevacizumab
Topotecan Hydrochloride
Pemetrexed Disodium
Crizotinib
Paclitaxel Albumin-stabilized Nanoparticle Formulation
Afatinib Dimaleate
Ramucirumab
Ceritinib
2015-2020
Nivolumab
Pembrolizumab
Osimertinib
Alectinib
Necitumumab
Durvalumab
Dabrafenib
Brigatinib
Trametinib
Atezolizumab
Lorlatinib
Dacomitinib
Afatinib
Larotrectinib
Entrectinib
Selpercatinib
Capmatinib