In a year full of challenges for everyone, there was a silver lining for lung cancer patients in the form of the abundance of new approvals by the Food and Drug Administration (FDA). In 2020 there were approvals for both new immunotherapies as well as targeted therapies that provide patients with options for treatment that were previously not available to them. In addition to the newly approved treatment options, the FDA approved two new methods of biomarker testing for patients.

How Biomarker Testing Approvals Might Affect You

In August of 2020 the FDA approved the Guardant 360 CDx and the FoundationOne Liquid CDx for liquid biopsy to test for many lung cancer biomarkers at one time. Liquid biopsies are a non-invasive, done by a blood draw, way for doctors to test if stage 4 patients have any biomarkers for which they can prescribe an approved treatment. Along with being non-invasive, liquid biopsies could be beneficial to you because there is no worry that there will not be enough tissue to test for as many genes as necessary through next generation sequencing (NGS). With FDA approval for these new liquid biopsies it will be easier for you to receive potentially life changing biomarker testing and insurance coverage gaps will become less pronounced as both are covered by Medicare.

Immunotherapies Approved by The FDA in 2020

In 2020 the FDA both approved new immunotherapies as well as made previously approved drugs available to more people. The FDA designated new approval for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) with platinum doublet chemotherapy in the first line for any patients with no actionable changes or without platinum doublet chemotherapy for patients with more than 1% PD-L1. Keytruda (pembrolizumab) is now also available for patients with a high tumor mutational burden (TMB – High) as determined by an appropriate biomarker test. Patients with more than 50% PD-L1 may now receive Tecentriq (atezolizumab) without the addition of chemotherapy. In addition to giving more patients access to previously approved drugs, the FDA has extended the dosing schedules fir Keytruda and Imfinzi (durvalumab) so that patients on those drugs can receive their treatment less often. These new approvals and widened access to previously approved drugs provides patients with more options than ever before.

Targeted Therapies Approved by The FDA in 2020

In 2020 the FDA both approved new targeted therapies as well as made previously approved drugs available to more people. The FDA has approved the combination of two previously approved drugs, Cyramza (ramucirumab) and Tarceva (erlotinib), for patients with an EGFR mutation. In addition to this repurposing of previously approved treatments, the FDA has approved four new drugs in 2020. Patients with changes in ALK now have access to Alunbrig (brigatinib). Patients with changes in MET now have access to Tabrecta (capmatinib). Patients with changes in RET now have access to both Gavreto (pralsetinib) and Retevmo (selpercatinib). These new approvals provide some patients with no previously approved targeted therapies access to drugs specific for their type of cancer.

Small Cell Lung Cancer Treatments Approved by The FDA in 2020

In 2020 the FDA approved new drugs for extensive small cell lung cancer (E-SCLC). Patients with E-SCLC now have access to a new immunotherapy, Imfinzi (durvalumab), in combination with platinum doublet chemotherapy. Additionally, E-SCLC patients who have tried platinum doublet chemotherapy in the past now have access to the new chemotherapy Zepzelca (lurbinectedin).

If you have any questions about how any of these drugs or diagnostics apply to you or could change your treatment journey, call our LungMATCH specialists at 1-800-298-2436 or email us at support@go2.org

If you are interested in receiving information about new drug approvals, upcoming clinical trials, or what other research at GO2 for Lung Cancer could benefit you, please register for our new clinical trials newsletter by emailing Daniel Saez at dsaez@go2.org