Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced that the ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase 3 trial eval­u­ating the safety and efficacy of ixazomib, the first oral pro­te­a­some inhibitor, conducted in patients with re­lapsed or refractory multiple myeloma (MM) achieved its pri­mary end­point of im­prov­ing pro­gres­sion-free survival at the first pre-specified interim analysis. In the trial, patients treated with inves­ti­ga­tional ixazomib plus lena­lido­mide and dexa­meth­a­sone lived without their disease worsening for a sig­nif­i­cantly longer time compared to patients who received placebo plus lena­lido­mide/dexamethasone.

Efficacy …

US Submission Designed to Support Conversion From Accelerated to Full FDA Approval and Expansion of Current Approved Indication
EMA Grants Kyprolis Accelerated Assessment and Orphan Drug Desig­na­tion

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ:AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) and a Marketing Authorization Ap­pli­cation (MAA) to the European Medicines Agency (EMA) for Kyprolis® (car­filz­o­mib) for Injection to seek approval for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. In the U.S., the sNDA is designed to sup­port the conversion of accelerated approval …

• Approval is being sought for use as a high-dose conditioning treatment prior to stem cell transplantation in multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
• The Company expects FDA review to take approximately 10 months.
• The Company plans to launch this drug with its existing hematology/oncology sales force next year pending approval.
• Our formulation is free of propylene glycol and does not use a custom solvent

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Boudry, Switzerland (Press Release) – 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 continuous oral treat­ment with REVLIMID^® in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for stem cell trans­plan­ta­tion.

The CHMP reviews appli­ca­tions for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Com­mis­sion, which generally follows the recom­men­da­tion of the CHMP, is ex­pec­ted to make its final de­ci­sion in approx­i­mately …

– Data Featured as Oral Presentation at ASH 2014 –

San Francisco (Press Release) –Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced results from an open-label, Phase 2 study eval­u­ating the safety and efficacy of oral, single-agent ixazomib (MLN9708) as main­te­nance ther­apy in patients with multiple myeloma (MM) who had received ixazomib, lena­lido­mide and dexa­meth­a­sone as induction ther­apy. The data from this trial dem­onstrate the poten­tial feasibility of single-agent ixazomib main­te­nance ther­apy fol­low­ing 12 cycles of ixazomib-lenalidomide-dexamethasone, with deepening responses and an acceptable tolerability profile. These data were presented today at the 56th American Society of Hematology (ASH) …

San Francisco, CA (Press Release) – New treat­ment com­bi­na­tions and targeted ther­a­pies for lym­phoma and multiple myeloma are improving out­comes for vulnerable patient pop­u­la­tions with hard-to-treat disease, according to studies presented today at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition.

Despite ad­vances in lym­phoma treat­ments, improving the prognosis for patients with re­lapsed and treat­ment-resistant disease remains a chal­lenge. The early success of several precision ther­a­pies asso­ci­ated with fewer side effects than conventional ap­proaches offers new hope for conquering aggressive disease. For lym­phoma patients who relapse or do not respond …

Basel, Switzerland (Press Release) - Novartis announced today that the US Food and Drug Admin­istra­tion (FDA) has extended their priority review period by up to three months for the new drug appli­ca­tion (NDA) of LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib* and dexa­meth­a­sone for patients with pre­vi­ously treated multiple myeloma.

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