Protocols

Takeda receives additional FDA approval for GI drug; Cancer Research UK to test gemcitabine for advanced pancreatic cancer

→ The FDA has given the green light to Takeda to extended the indication of its drug Gattex (teduglutide) for injection to pediatric patients 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

→ More than a decade after the FDA first approved Fragmin to treat blood clots in adults, Pfizer has won an OK to extend its use in pediatric patients as young as one month old. There’d been no FDA-approved therapies to treat venous thromboembolism in this population, Richard Pazdur said in a statement, who are often suffering from a serious underlying condition such as cancer and congenital heart disease. The approval was based on a single trial with 38 patients, in which “21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.”

→ After whipping up some buzz around its gene therapy for “bubble boy disease” with early but hopeful data, Mustang Bio has scored an orphan drug designation for another asset in its pipeline: an oncolytic virus to treat malignant glioma, an aggressive type of brain cancer. The New York-based biotech is licensed the program from Nationwide Children’s Hospital, with the intention to combine it with its anti-CD213a2 CAR-T therapy.

→ The Cancer Research UK announced today that it will begin a clinical trial to test gemcitabine in advanced pancreatic cancer. The organization says that “the study will use PLX7486 to target Trk kinases, which are believed to help cancer cells invade nerves. It’s hoped that PLX7486, in combination with the chemotherapy drug gemcitabine, could improve progression-free survival and reduce pain for pancreatic cancer patients.” The trial will be conducted through the Experimental Cancer Medicine Centre (ECMC) network, supported by Cancer Research UK and the UK Health Departments and let by the Manchester ECMC and sponsored by the University of Glasgow Clinical Trials Unit. The first patients can expect to start treatments in early June and the trial will span four sites across the UK.

Natalie Cook, chief investigator of the trial and clinical lead of the Manchester ECMC, said: “Preclinical models show that giving this drug combination seems effective at stopping the cancer cells growing and multiplying. Hopefully, this will translate into clinical benefits and enable us to better control the pain and spread of cancer in patients.”

 


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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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