Olaparib is a small-molecule poly (ADP-ribose) polymerase (PARP) inhibitor. AstraZeneca filed for approval by the US Food and Drug Administration (FDA) in the first quarter of 2014 using subgroup results from a Phase II trial (which was known as Study 19) that showed that progression-free survival (PFS) was longer in patients with platinum-sensitive, relapsed ovarian cancer with BRCA mutations who were taking olaparib compared with placebo (11.2 months versus 4.3 months). In June 2014, the FDA's Oncologic Drugs Advisory Committee voted 11 to 2 to delay market approval until the results are released from the Phase III SOLO-2 trial, which is recruiting only patients with BRCA mutations. The panellists were concerned that patients who received olaparib may have had worse response rates with subsequent lines of chemotherapy, thus attenuating an overall survival benefit. Top-line data release from SOLO-2 is not expected until the third quarter of 2015, and so we anticipate that AstraZeneca will receive a complete response letter, assuming that the FDA follows the advisory committee recommendation. The Prescription Drug User Fee Act date for a decision is 3 January 2015. In addition, marketing authorization for olaparib in Europe is expected to be granted during the first quarter of 2015 following a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in October 2014.

Indoximod is a small-molecule inhibitor of indoleamine 2,3-dioxygenase (IDO) and is in development for solid tumours, including breast, brain and pancreatic cancer as well as melanoma. Initial Phase I studies indicated signs of activity, and showed that indoximod has good oral bioavailability and a favourable half-life and is tolerated well by patients. NewLink Genetics expects preliminary top-line results for Phase II trials in all four oncology indications in the first quarter of 2015, which could provide a significant market boost to the company if success is seen in any of these hard-to-treat cancers.

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