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– First Presentation of Interim Phase 1/2 Data Reported in Pediatric Patients with Relapsed or Refractory Hodgkin Lymphoma or relapsed or refractory Systemic Anaplastic Large Cell Lymphoma -

CHICAGO & OSAKA, Japan - Saturday, June 1st 2013 [ME NewsWire]

2013 ASCO Annual Meeting

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) today announced interim data from a Phase 1/2, open-label, multicenter study with ADCETRIS® (brentuximab vedotin) in pediatric patients diagnosed with CD30-positive relapsed or refractory Hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Data were presented from the Phase 1 portion of the study, which evaluated the safety, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) of ADCETRIS. The results were reported during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held May 31 – June 4, ... Read more »

BOUDRY, Switzerland - Saturday, June 1st 2013 [ME NewsWire]

--(BUSINESS WIRE)-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency’s (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Pomalidomide Celgene in combination with dexamethasone for the treatment of relapsed and refractory multiple myeloma (rrMM) in patients who have received at least two prior therapies, including both lenalidomide and bortezomib, and have demonstrated disease progression while on their last therapy.

The CHMP reviews applications for all 27 member states in the European Union (EU), as well as Norway and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months.

Multiple Myeloma (MM) is a rare blood cancer in which plasma cells, important components of the ... Read more »

RESEARCH TRIANGLE PARK, N.C - Saturday, June 1st 2013 [ME NewsWire]

(BUSINESS WIRE)-- In advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, Quintiles today announced the release of its perspective on two areas of focus for clinical oncologists – the impact of patient selection in early-phase studies and the use of biomarkers in the treatment of hematologic malignancies.

The first of these reports, Tomorrow’s Path to Improved Early-Phase Oncology Drug Development, explores the importance of key elements to maximize quality and efficiency of go/no-go decisions in early-phase studies. As the understanding of the biology of cancer becomes more sophisticated and generates more opportunities, fundamental challenges caused by the complexities of this group of diseases are becoming more evident. Molecular profiling and leveraging molecular selection of patients has the potential to significantly improve the quality of early decisions in oncology drug deve ... Read more »