Faced with a pandemic that kills thousands of Americans each day, FDA leadership had to get therapeutics and vaccines for SARS-CoV-2 onto the market with unprecedented speed without sacrificing standards.
When Uğur Şahin and his wife Özlem Türeci founded their company, BioNTech, in 2008, they set out to explore novel modalities for treating cancer—including messenger ribonucleic acid, a well-understood single-stranded molecule featured in most Biology 101 textbooks.
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee recommended against an accelerated approval for Keytruda for patients with high-risk, early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery.
Being Black and running an NCI-designated cancer center at a time of a worldwide pandemic, an ugly election, and a racial reckoning in a Southern town puts you in a position to make profound observations.
Pandemic notwithstanding, NCI is on track to reach the 15th percentile for the payline by 2025—a goal set by institute Director Ned Sharpless in response to a deluge of grant applications.
FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
FDA has granted accelerated approval to Darzalex Faspro (daratumumab plus hyaluronidase) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
FDA has accepted the supplemental Biologics License Application of Opdivo (nivolumab) for the treatment of patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy.
FDA has accepted the supplemental Biologics License Application for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.
FDA has made labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection.
