Zydelig US Indications Withdrawn for Follicular Lymphoma, Small Lymphocytic Leukemia
Continued approval required further verification and description of clinical benefit in confirmatory trials.
Oncology
HHS Carcinogen Report Updated to Include 8 Substances
The US Department of HHS added 8 new substances to the 15th Report on Carcinogens, bringing the total list to 256 substances.
Silmitasertib Granted Orphan Drug Status for Medulloblastoma
Silmitasertib is a first-in-class potent and highly selective inhibitor of casein kinase 2 (CK2).
Tocilizumab Shortage Prompts Temporary REMS Change for CAR T-Cell Therapy
Shortly after an EUA was issued, Genentech announced that tocilizumab (marketed under the brand name Actemra) was in shortage.
Keytruda Approved for Adjuvant Treatment IIB, IIC Melanoma Following Resection
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
Copiktra Indication for Relapsed/Refractory Follicular Lymphoma Withdrawn
The Company will be working with the FDA in the coming weeks to complete the label revision process.
Rinvoq Labeling Updated to Include Class Warnings Related to JAK Inhibitors
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
FDA Approves Rituxan Plus Chemotherapy for Certain Pediatric Hematologic Cancers
The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial.
Clinical Challenge: Generalized Weakness and Dehydration
A 63-year-old man with a history of thyroid cancer presents to the emergency department with a 4-day history of generalized weakness and lack of interest in food or drink. Read how this case unfolded.
FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
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