Kymriah (tisagenlecleucel) became the first gene therapy available in the United States.
FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).
FDA granted regular approval to olaparib tablets (Lynparza) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. FDA granted this application Fast Track status.
Peter Pisters, a sarcoma and pancreatic cancer surgeon and an MD Anderson expat who serves as president and CEO of University Health Network of Toronto, is set to become the fifth president of the Houston-based cancer center.
NCI is asking for $6.38 billion for fiscal year 2019—nearly $1 billion, or 12 percent, above FY17 appropriation levels—to fully fund promising research areas.
Ocugen Inc. said FDA has granted orphan drug designation for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease.
On behalf of FDA, on Aug. 25 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live), a vaccine reserved for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.
A SWOG study estimates that implementation of findings from that group's clinical trials has added 3.34 million years to the lives of cancer patients in the 60 years since its founding in 1956.
The Neuroendocrine Tumor Research Foundation announced a new round of scientific and clinical research grants, aimed at advancing the treatment of and the search for cures to neuroendocrine tumors.
FDA granted a regular approval to enasidenib (IDHIFA) for the treatment of adult patients with relapsed/refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test.
