Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that a New Drug Application (NDA) has been submitted to the United States (U.S.) Food and Drug Admin­istra­tion (FDA) for ixazomib, an inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma.

The NDA sub­mission was based on the pivotal Phase 3 trial TOURMALINE-MM1, an inter­na­tional, ran­dom­ized, double-blind, placebo controlled clin­i­cal trial of 722 patients designed to eval­u­ate the superiority of ixazomib plus lena­lido­mide and dex­a­meth­a­sone over placebo plus lena­lido­mide and …

Submission of rolling BLA to US FDA for dara­tu­mu­mab in multiple myeloma com­pleted by Janssen Biotech, Inc.

Completion of sub­mission triggers USD 15 million mile­stone pay­ment to Genmab

Copenhagen, Denmark (Press Release) — Genmab A/S (OMX: GEN) announced its licensing partner Janssen Biotech, Inc. has com­pleted the rolling sub­mission of the Biologics License Application (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for dara­tu­mu­mab. The sub­mission is for dara­tu­mu­mab as a treat­ment for patients with multiple mye­lo­ma who have received at least three prior lines of ther­apy in­­clud­ing both a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a PI and an IMiD. In May, 2013, dara­tu­mu­mab was granted a Break­through Therapy …

• Farydak (panobinostat) combination improved PFS by 7.8 months for patients who received >=2 prior regimens including bortezomib and an IMiD[1]
• Farydak would be the first HDAC inhibitor with epigenetic activity to treat multiple myeloma[2],[3]
• CHMP positive opinion marks a key milestone toward panobinostat availability in the EU, aligning with recent US FDA approval

Basel, Switzerland (Press Release) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion …

As I wrote last month, in early June I went to the Mayo Clinic in Rochester, Minne­sota, at the suggestion of my on­col­o­gist to get a second opinion on my cancer.

There are many ways to tell the same story.

This is one way. I have relapsed. The myeloma is pro­gress­ing at the same in­ex­orable glacial pace that has marked it for the last decade. I have stopped tak­ing Revlimid (lena­lido­mide) and will begin Kyprolis (car­filz­o­mib) at some un­de­ter­mined date.

There are many ways to tell the same …

Janssen Biotech, Inc. ini­ti­ates rolling sub­mission of BLA to U.S. FDA for dara­tu­mu­mab in double refractory multiple myeloma

Submission based on data from Phase II study (Sirius MMY2002)

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today its licensing partner Janssen Biotech, Inc. has ini­ti­ated a rolling sub­mission of a Biologics License Application (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for dara­tu­mu­mab. The sub­mission is for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who have received at least three dif­fer­en­t lines of ther­apy in­­clud­ing both a pro­tea­some inhibitor and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a pro­tea­some inhibitor and an IMiD. A rolling sub­mission allows com­pleted portions of the …

Marks a critical step for­ward for the inves­ti­ga­tional human mono­clonal anti­body (mAb)

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) has ini­ti­ated the rolling sub­mission of its Biologic License Application (BLA) for dara­tu­mu­mab to the U.S. Food and Drug Admin­is­tra­tion (FDA) for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are double refractory to a PI and an IMiD. Dara­tu­mu­mab – an inves­ti­ga­tional human anti-CD38 mono­clonal anti­body – received Break­through Therapy Desig­na­tion by the FDA for this set of patients …

The pivotal study will assess the efficacy of plitidepsin plus dexa­meth­a­sone versus dexamethasone alone in patients with re­lapsed / refractory multiple myeloma

Madrid (Press Release) – PharmaMar announced today that the patient recruitment for the pivotal Phase III trial of APLIDIN® (plitidepsin) for the treat­ment of multiple myeloma, denominated ADMYRE, has been suc­cessfully com­pleted. The study, which originally planned to in­clude 250 patients, has enrolled 255 patients in 71 medical centers world­wide, in­­clud­ing the US, Europe, Asia, South America, Australia, and New Zealand. An appli­ca­tion for market­ing authori­za­tion in Europe is planned to be submitted in 2016.

ADMYRE …