The poten­tial new myeloma ther­apy daratumumab just got a little closer to being avail­able to U.S. multiple myeloma patients outside of clin­i­cal trials.

Johnson and Johnson (NYSE:JNJ) announced today that its Janssen sub­sid­i­ary has started the process of applying to the U.S. Food and Drug Admin­istra­tion (FDA) to have dara­tu­mu­mab approved as a new treat­ment for re­lapsed multiple myeloma.

In particular, Johnson and Johnson has started a rolling sub­mission of a biologics license appli­ca­tion to the FDA for dara­tu­mu­mab.

A rolling sub­mission allows Johnson and Jonson to submit com­pleted portions of …

Aktualisierte Ergebnisse einer Phase 1/2-Schlüsselstudie, die die potenzielle neue Myelomtherapie Daratumumab prüft, wurden heute Morgen veröffentlicht. Die neuen Ergebnisse bestätigen die bisherige Forschung, die zeigt, dass die Einzelsubstanz  Daratumumab eine bemerkenswerte Wirkung als Myelomtherapie hat.

Im Einzelnen zeigen die Ergebnisse, dass fast ein Drittel der Studienteilnehmer - die eine mittlere Anzahl von fünf Vortherapien erhalten hatten – auf die Einzelsubstanz Daratumumab ansprachen. Die mittlere Zeit bis zur Progression betrug 3,7 Monate, und die geschätzte einjährige Gesamtüberlebenrate betrug 65 Prozent.

Das Sicherheitsprofil von Daratumumab in der Studie war günstig. Nur 5 Prozent der …

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 …

Updated results of a key Phase 1/2 trial testing the poten­tial new myeloma ther­a­py daratumumab were released this morning. The new results con­firm pre­vi­ous research indicating that single-agent dara­tu­mu­mab has notable activity as a multiple myeloma ther­apy.

Specifically, the results show that nearly one third of the trial par­tic­i­pants – who had received a median of five prior ther­a­pies – responded to single-agent dara­tumumab. The median time to disease pro­gres­sion was 3.7 months, and the esti­mated one-year over­all survival rate was 65 per­cent.

Daratumumab’s safety profile in the trial was …

The 51st annual meeting of the American Society of Clinical Oncology (ASCO) started earlier to­day, May 29, and will go through June 2 in Chicago.

Approximately 30,000 physicians and re­searchers from all over the world are ex­pec­ted to attend the five-day meeting to discuss cur­rent re­search in cancer treat­ment and care.

During the meeting, there will be pre­sen­ta­tions about all types of cancer, in­clud­ing many pre­sen­ta­tions focused spe­cif­i­cally on mul­ti­ple myeloma. In fact, more than 90 myeloma-related stud­ies are scheduled to be pre­sented, in one form or another, in con­nec­tion with the …

A new year is upon us.  I hope it has started well for everybody, and that all had a great holiday season!

The last few weeks of 2014 were a hap­pen­ing time for the mul­ti­ple myeloma com­munity. The short span of time witnessed the pub­li­ca­tion of up­dated criteria for the diag­nosis of mul­ti­ple myeloma from the Inter­na­tional Myeloma Work­ing Group (IMWG). In addi­tion, the 56^th annual meeting of the American Society of He­ma­tol­ogy (ASH) took place in San Francisco, with literally hundreds of myeloma-related oral and poster pre­sen­ta­tions.

Therefore, it is again …