Celgene says ozanimod regulatory submissions on-track for Q1

Overview of Key Milestones Expected Over the Next 12 Months: REVLIMID: Approval expected by the U.S. Food and Drug Administration on the supplemental New Drug Application for REVLIMID in combination with rituximab in relapsed/refractory indolent lymphoma. Approval expected by the European Medicines Agency’s Committee for Medicinal Products for Human Use for REVLIMID in combination with bortezomib and dexamethasone in newly diagnosed multiple myeloma. Data expected from the phase III ROBUST trial with REVLIMID in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in patients with first-line ABC-subtype diffuse large B-cell lymphoma. POMALYST/ IMNOVID: Approval expected by the EMA CHMP and Japan Pharmaceuticals and Medical Devices Agency for POMALYST/IMNOVID in combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. OTEZLA: Approval expected by the U.S. FDA for the sNDA in Behet’s disease with a Prescription Drug User Fee Act action date of July 21, 2019. Approval by the PMDA in Japan is expected in H2:2019. Submission of the sNDA with label update for moderate to severe scalp psoriasis to the U.S. FDA expected in Q2:2019. ABRAXANE: Data from the phase III apact trial with ABRAXANE as adjuvant therapy in patients with surgically resected pancreatic cancer. PDUFA action date of March 12, 2019 for the supplemental Biologics License Application submission filed by Roche of Tecentriq in combination with ABRAXANE for the initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer. Milestones Expected for Key Pivotal Assets: Ozanimod: U.S. NDA and EU Marketing Authorization Application submissions in relapsing multiple sclerosis on-track for Q1:2019. Phase III TRUE NORTH trial in ulcerative colitis expected to complete enrollment in H1:2019. Fedratinib: U.S. FDA approval expected by year-end 2019. EU MAA submission planned in H1:2019. Phase I/II combination trial with luspatercept planned. Luspatercept: U.S. and EU regulatory applications for transfusion-dependent, lower-risk myelodysplastic syndromes with ring sideroblasts and transfusion-dependent beta-thalassemia planned for H1:2019. Data expected from the phase II myelofibrosis trial in H2:2019. Liso-cel: Data from the pivotal TRANSCEND trial in relapsed/refractory DLBCL expected in 2019. U.S. BLA submission expected in H2:2019. Pivotal phase II trial in relapsed/refractory chronic lymphocytic leukemia to be initiated in H1:2019. bb2121: Data from the KarMMa pivotal trial in RRMM expected in H2:2019: Phase II trial in NDMM to be initiated in H2:2019.

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