FDA

FDA Roundup: Second COVID-19 Vaccine, Lung Cancer, Prostate Cancer

Emergency Authorization1

The US Food and Drug Administration has issued an emergency use authorization for the Moderna COVID-19 vaccine, allowing the vaccine to be distributed in the US to individuals aged 18 years and older.

The vaccine is given as a 2-dose series one month apart. The safety and effectiveness of the vaccine were evaluated in an analysis of 30,351 patients from an ongoing randomized, placebo-controlled study. Of the participants, 15,185 received the vaccine and 15,166 received placebo.

Common side effects included tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes, nausea, and fever.

Lung Cancer2

The FDA has approved Tagrisso (osimertinib), the first adjuvant treatment for patients with non-small cell lung cancer (NSCLC) who have tumors with a specific type of genetic mutation.

The treatment was evaluated in a randomized, double-blind, placebo-controlled trial of 682 patients with NSCLC and EGFR exon 19 deletions or exon 21 L858R mutation-positive. Overall, those given osimertinib had an 80% decrease in the chance of disease recurrence compared with individuals given placebo.

Common side effects included diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation, sore mouth, fatigue, and cough.

Prostate Cancer3

The FDA has approved Orgovyx (relugolix) for the treatment of adults with advanced prostate cancer.

The safety and efficacy of the drug were evaluated in a randomize,d open-label trial including 622 men who received Orgovyx once daily. Overall, among those given the drug, the castration rate was 96.7%.

The most common side effects included hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of liver enzymes.

References:

  1. US Food and Drug Administration. FDA Takes Additional Action in Fight Against COVID-19 by issuing emergency use authorization for second COVID-19 vaccine. News release. December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid
  2. US Food and Drug Administration. FDA approves first adjuvant therapy for most common type of lung cancer. News release. December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-adjuvant-therapy-most-common-type-lung-cancer
  3. US Food and Drug Administration. FDA approves first oral hormone therapy for treating advanced prostate cancer. December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer