Clinical

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Articles


In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.


FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma 

I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.

FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy

Doctors surveyed by the Association for Clinical Oncology said payer prior authorization can cause disease progression and loss of life.

Survey: Oncology Doctors Say Prior Authorization Hurts Patients

A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.


Genentech Withdraws Tecentriq Indication for Bladder Cancer

An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.
 


FDA Issues CRL for Poziotinib for Lung Cancer

A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.

GSK Pulls Blenrep from U.S. Market

If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.

FDA Accepts for Priority Review BLA for Epcoritamab

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

FDA Approves Alternate Dosing Schedule for Rylaze


After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.


 GSK Limits Use of Zejula for Some Cancer Patients 


Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.

