On Oct. 2, 2015, the FDA is expected to
make its decision as to whether or not to expand the label of Keytruda, a
cancer immunotherapy developed by Merck, to include patients with advanced non-small cell lung cancer.
Merrimack's MM-398, a
treatment for pancreatic cancer that has a PDUFA decision date of Oct.
24, 2015. Among cancer types, few offer a more discouraging long-term
survival rate than pancreatic cancer. Merrimack's MM-398 didn't cure
patients' pancreatic cancer in the NAPOLI-1 trial, but it did
demonstrate a more durable response that led to a statistically
significant improvement in median overall survival. Overall median
survival for the MM-398 arm in combination with 5-fluorouracil and
leucovorin rose to 6.1 months from 4.2 months in the control arm without
MM-398.
Amgen with its cancer immunotherapy, talimogene laherparepvec (also known as T-Vec).
T-Vec is a reengineered herpes simplex
virus designed to replicate inside cancer cells to make them burst. In
addition, it draws the attention of the immune system, eliciting a
response. Specifically, T-Vec is being targeted as a treatment for
advanced melanoma, although combining the drug with other cancer
immunotherapies and/or tackling other cancer indications does seem to be
in the cards if T-Vec wins approval from the FDA on or before its PDUFA
decision date of Oct. 27, 2015.
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