About two months ahead of the planned PDUFA date, the U.S. FDA has granted expanded approval of PD-1 antibody Jemperli (dostarlimab) from partners Anaptysbio Inc. and GSK plc for use in combination with standard-of-care chemotherapy. GSK said the drug would be the only frontline immuno-oncology treatment for endometrial cancer available in combination with carboplatin and paclitaxel. The supporting supplemental BLA for the expanded indication previously received priority review.
UC Davis Comprehensive Cancer Center is partnering with Targagenix Inc. and Northeastern University to study pancreatic ductal adenocarcinoma (PDAC). The partnership will receive nearly US$3 million over 5 years through funding from the National Institutes of Health (NIH).
CV6 Therapeutics Ltd. raised $9.2 million in grant and equity funding to move a first-in-class inhibitor of deoxyuridine 5’-triphosphate nucleotidohydrolase (dUTPase) into a phase Ia trial in cancer. The compound, CV6-168, will from the outset be administered in combination with fluorouracil, a mainstay of chemotherapy for the past 60 years.
Researchers have identified an RNA-binding protein that played a role in colon cancer relapse, offering new insights into how cells persist in the presence of chemotherapy.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
The share price of Renovorx Inc. has spiked following FDA clearance for its Renovocath delivery system. Since the company announced the clearance, its stock (NASDAQ:RNXT) has climbed by more than 13%. Last month the company completed an IPO for approximately $16.6 million, issuing shares at $9-$11.
Local tumor conversion of a prodrug to an active agent using clinically relevant radiotherapy may herald a new era in targeted and directed cancer chemotherapy.
A study led by scientists at Osaka University Graduate School of Medicine has identified the previously unknown molecular mechanism underlying bone marrow regeneration after chemotherapy, which damages hematopoietic stem and progenitor cells.
