The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).
Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL), chair of the Senate Judiciary Committee, Thom Tillis (R-NC), and Chris Coons (D-DE) to introduce bipartisan legislation that would establish a task force between the United States Patent and Trademark Office and FDA to improve communication and coordination in implementing each agency’s activities related to patents.
FDA approved Keytruda (pembrolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for stage 1B, 2, or 3A non-small cell lung cancer.
FDA approved Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Over and over again, I’ve seen the same missteps, clumsy excuses, and faulty logic during sponsor presentations to the FDA Oncologic Drugs Advisory Committee, repeated as if part of a tragic, regulatory update to the movie Groundhog Day.
FDA granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
FDA issued a draft guidance for industry, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.”
FDA has accepted Genentech’s Biologics License Application and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
FDA granted accelerated approval to Lunsumio (mosunetuzumab-axgb), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.
