Tags : Recurrent

Regulatory

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy

Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% […]Read More

Regulatory

Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for

Shots: The EC has approved two regimens of Keytruda (monothx. and in combination with platinum and 5-fluorouracil (5-FU) CT), based on P-III KEYNOTE-048 study evaluating Keytruda vs SoC (cetuximab with carboplatin/cisplatin + 5-FU) in 882 patients in a ratio (1:1:1) with confirmed metastatic or recurrent HNSCC prior not treated with systemic therapy and incurable by […]Read More

Pharma

Roche’s Rozlytrek (entrectinib) Receives MHLW’s Approval for NTRK Fusion-Positive Advanced

Shots: The approval is based on P-II STARTRK-2, P-I STARTRK-1, P-I ALKA-372-001 & P-I/II STARTRK-NG studies results assessing Rozlytrek in adults & pediatric patients with NTRK fusion-positive solid tumors, across 10 different tumor types, including CNS metastases solid tumors across 15 countries in 150+ clinical studies respectively   The P-II STARTRK-2 study demonstrated that Rozlytrek […]Read More

Biotech

ONO Pharmaceutical Reports Results of Opdivo (Nivolumab) in P-III ATTRACTION-3

Shots:  The P-III ATTRACTION-3 study involves assessing of Opdivo (involumab, IV) vs CT (docetaxel/paclitaxel) in patients with unresectable advanced or recurrent esophageal cancer or intolerant to fluoropyrimidine + PT-based drug The study demonstrated in meeting 1EPs with superiority in overall survival of Opdivo vs CT Opdivo(Nivolumab) is a PD-1 immune checkpoint inhibitor targeted against cancer […]Read More