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The FDA has approved the use of Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. "This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain," said John Jenkins, MD, Director of FDA's Office of New Drugs.


Abstral, made by ProStraken Inc., is indicated for adult patients with cancer at least 18 years old who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid. The approval notes that only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.


Also newly approved is a new indication for rituximab (Rituxan), for maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with induction treatment of rituximab plus chemotherapy. The approval is based on results of the Phase III PRIMA study of 1,217 patients, showing that continuing therapy every two months for two years in patients who responded to initial treatment with rituximab plus chemotherapy nearly doubled the likelihood of progression-free survival compared with those who stopped treatment.


The FDA also granted Orphan Drug Designation to the focal adhesion kinase inhibitor CFAK-C4, made by CureFAKtor Pharmaceuticals, for treatment of pancreatic cancer.


A news release notes that a Phase I clinical study is now being planned of CFAK-C4 in combination with gemcitabine, the current standard of care for pancreatic cancer.


CureFAKtor Pharmaceuticals was formed in 2008 based on discoveries by William Cance, MD, of Roswell Park Cancer Institute. The Company has to date been funded primarily by grants from the NIH, the news release notes. Other cofounders of the company are two other Roswell Park researchers who have also made discoveries that are being studied, Elena Kurenova, PhD, and Vita Golubovskaya, PhD.