Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its re­quest for an accelerated assess­ment of the dara­tu­mu­mab Marketing Authorisation Application (MAA). This acceptance follows the earlier regu­la­tory sub­mission of a MAA which seeks authori­sa­tion of dara­tu­mu­mab as a single agent for the treat­ment of patients with re­lapsed and refractory multiple myeloma and is cur­rently pend­ing val­i­da­tion by the EMA.

The CHMP grants accelerated assess­ment when a medicinal prod­uct is ex­pec­ted to be …

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for dara­tu­mu­mab, an in­ves­ti­ga­tional, human anti-CD38 mono­clonal anti­body, for the treat­ment of patients with re­lapsed and refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is char­ac­ter­ised by excess growth and survival of malignant plasma cells.^[1] Patients who are refractory to both pro­te­a­some inhibitors (PIs) or immuno­modu­la­tory agents (IMiDs) have a poor prognosis, with an esti­mated median over­all survival of …

If approved, dara­tu­mu­mab will offer a new option for double refractory, heavily pre-treated patients

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for Priority Review the Biologics License Application (BLA) for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who are refractory to both a pro­tea­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who have received three or more prior lines of ther­apy, in­­clud­ing a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has be­come resistant to at least …

• U.S. FDA grants Priority Review to dara­tu­mu­mab
• PDUFA target date has been set to March 9, 2016

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review to the Biologics License Application (BLA) for dara­tu­mu­mab. The BLA 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 BLA sub­mission was started by Genmab’s …

The American Society of Clinical Oncology (ASCO) meeting in any given year is hit-or-miss as far as breaking research for multiple myeloma goes.

However, at ASCO 2015, there were no two views among myeloma experts. It was probably one of the most sig­nif­i­cant ASCO meetings as far as pre­senta­tions of abstracts that have the poten­tial to alter the land­scape of myeloma treat­ment in the near future.

There is no way to do justice to all the presentations at ASCO this year. However, I have tried to prepare a quiz to high­light …

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 …

A new pro­gram has been started that will make it easier for re­lapsed mul­ti­ple myeloma patients in the United States to be treated with the in­ves­ti­ga­tion­al drug daratumumab.

Johnson & Johnson (NYSE:JNJ), which is devel­op­ing dara­tu­mu­mab in col­lab­o­ra­tion with the Danish bio­technology com­pany Genmab, has ini­ti­at­ed an “ex­panded access pro­gram” – a special kind of clin­i­cal trial – to broaden op­por­tu­ni­ties for qualify­ing U.S. myeloma patients to be treated with the drug.

The pro­gram is ex­pec­ted to remain in place until a de­ci­sion is made by the U.S. Food & …