Food and Drug Administration (FDA) regarding a special protocol assessment (SPA) for its planned Phase 3 study of Marqibo(R) (vincristine sulfate liposomes injection) in adults with newly diagnosed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
and its affiliates for which CASI has exclusive rights to the greater China market, consisting of EVOMELA (Melphalan Hydrochloride for Injection), ZEVALIN (Ibritumomab Tiuxetan) and MARQIBO (Vincristine Sulfate Liposome Injection) and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs), including entecavir and tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus.
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.