FDA Amends Approval of Pembrolizumab to Treat Stomach and Esophageal Junction CancerSubscribeNovember 17, 2023, by Carmen PhillipsTreatment for HER2-positive stomach and gastroesophageal junction cancers is expected to change based on an update to the Food and Drug Administration's 2021 accelerated approval of pembrolizumab (Keytruda) for these cancers.Credit: iStockNOTE: This story was updated on November 21, 2023, to reflect the Food and Drug Administration's approval of pembrolizumab plus chemotherapy for HER2-negative gastric cancer and gastroesophageal junction cancer.The Food and Drug Administration (FDA) has amended its 2021 accelerated approval of the immunotherapy drug pembrolizumab (Keytruda) as part of treatment for some people with advanced stomach cancer and gastroesophageal junction (GEJ) cancer.The initial approval covered the use of pembrolizumab along with trastuzumab (Herceptin) and chemotherapy for people with advanced HER2-positive stomach (or gastric) or GEJ cancer, meaning that their tumors produced high levels of the protein HER2. Under the updated approval, announced on November 9, pembrolizumab can now only be used for people with these cancers whose tumors also have high levels of another protein, PD-L1.

nice to see you back. Many agree, BP is needed to progress.
IMO, criticism of management, with regard to lack of a deal with Her VAXX, should be tempered, due to FDA giving accelerated approval for Keytruda’s use in advanced Gastroesophageal cancer. ( in 2021)
This altered in Nov 23, for only those with elevated PD-L1 levels.
Despite similar response rates, and no deleterious side effects, , it is hard to compete with Keytruda
IMO, there is a strong argument to gather approval still, particularly in third world countries, with a safer, cheaper option. I have not given up hope on a deal yet.
( Ahh for the old optimism in Bcell vaccines. I recall even a note on IMUs website on a PD-L1 vacc as a possibility, to go with HER and PD1 . How would that be for a combination ,,PD L1 and Her2)