FDA has accepted the Biologics License Application for idecabtagene vicleucel (ide-cel; bb2121) as Priority Review.
Agenus Inc. has begun the rolling submission of its Biologics License Application FDA for balstilimab alone for the treatment of recurrent/metastatic cervical cancer.
FDA has accepted and granted priority review to the supplemental New Drug Application for Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for GSK's Zejula (niraparib) as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
One in seven Black women with breast cancer had delays in starting treatment, and Black women also had extended duration of treatment, according to a study led by UNC Lineberger Comprehensive Cancer Center researchers.
A study led by researchers at Fred Hutchinson Cancer shows that iCanQuit app is one-and-a-half times more efficacious than the NCI QuitGuide app.
The phase III EORTC1325/KEYNOTE-054 trial evaluating Keytruda as adjuvant therapy in resected, high-risk stage III melanoma, met the key secondary endpoint of distant metastasis-free survival.
The phase III KEYNOTE-590 trial evaluating Keytruda in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer demonstrated a significant improvement in overall survival.
The phase III CheckMate -9ER trial, in which Opdivo (nivolumab)in combination with Cabometyx (cabozantinib) demonstrated significant improvements across all efficacy endpoints, including overall survival, in previously untreated advanced renal cell carcinoma.
Results from the phase III CheckMate -577 trial demonstrated that adjuvant treatment with Opdivo (nivolumab) showed a statistically significant and clinically meaningful improvement in disease-free survival, the trial's primary endpoint, compared to placebo in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and tumor resection.
