October 16th 2024
Results from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus standard-of-care achieved sustained disease control.
FDA Grants Priority Review to Pfizer and Genmab's Tivdak for Cervical Cancer Treatment
January 9th 2024Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
Novartis Announces Positive Findings for Scemblix in Newly Diagnosed Chronic Myeloid Leukemia
January 8th 2024Scemblix (asciminib) plus investigators’ choice of tyrosine kinase inhibitor showed clinically meaningful and statistically significant data in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec
January 4th 2024Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.
FDA Fast Tracks Candel Therapeutics' Novel Treatment for Pancreatic Ductal Adenocarcinoma
January 3rd 2024Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group.
GSK's Jemperli Plus Zejula Produces Significant Survival Improvement in Endometrial Cancer
December 18th 2023Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer.
FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer
December 15th 2023In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer.
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune
December 12th 2023Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer.
Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer
December 11th 2023Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.