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 treatment approvals since January 2018. Since 2018, there have been more than 20 approvals. Notably, 2018 also saw the first small cell lung cancer treatment approved in over a decade.
October 2020
- FDA approved FoundationOne CDx companion diagnostic test to help identify NTRK+ solid tumor patients eligible for larotrectinib. 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
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