During the first half of 2013, we expect a decision by the Committee for Medicinal Products for Human Use (CHMP) on REVLIMID for MDS deletion 5q and to complete enrollment in the phase III ORIGIN (CLL-008) trial in chronic lymphocytic leukemia.
Pomalidomide: The international phase III trial (MM-003) comparing pomalidomide with low-dose dexamethasone to high-dose dexamethasone in relapsed refractory multiple myeloma patients recently achieved the primary endpoint of progression-free survival, in addition to the key secondary endpoint of overall survival. The Phase I/II dose-ranging trial (MM-005) evaluating the combination of pomalidomide, dexamethasone and bortezomib continues with data expected at this year’s ASH meeting. The regulatory reviews of pomalidomide for relapsed refractory multiple myeloma are progressing with an FDA decision expected in February 2013 and a CHMP decision expected during the second half of 2013.
ABRAXANE: We are executing on the strategy to expand the label for ABRAXANE beyond the initial indication of metastatic breast cancer. In October, the FDA approved the second indication of ABRAXANE for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.The phase III trial evaluating ABRAXANE in metastatic melanoma achieved its primary endpoint of demonstrating a statistically significant improvement in progression-free survival compared to dacarbazine. Data will be presented at the Society for Melanoma Research meeting on November 11. Future regulatory and clinical strategies are being evaluated. Results from the phase III trial in metastatic pancreatic cancer are expected in the fourth quarter of 2012. This trial randomized over 840 patients to receive gemcitabine with or without ABRAXANE. The primary endpoint is overall survival. If successful, this trial would support a sNDA submission in 2013. Inflammation & Immunology Apremilast: The PALACE program (PALACE-1, 2 and 3) demonstrated a robust and statistically significant clinical benefit in previously treated psoriatic arthritis (PsA) patients. Overall safety was consistent with previous experience in the phase II program with an improved tolerability profile. We anticipate presenting the PALACE-1 data at a medical meeting before year-end. Results from PALACE-4 in treatment-naïve psoriatic arthritis are expected during the first half of 2013.