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Celgene’s Pomalyst And The Multiple Myeloma Market

February 1, 2013

       February 10, 2013, is the scheduled FDA PDUFA date for Celgene’s orphan drug Pomalyst (Pomalidomide) for the treatment of Relapsed and Refractory Multiple Myeloma (RRMM).

Generic Name Trade Name Sponsor Indication PDUFA Date
Pomalidomide Pomalyst Celgene Corporation Relapsed and Refractory   Multiple Myeloma (RRMM) 2/10/13

Please note the links for the following 2 chart columns above :

1) “Generic Name” Column Link = Is a source for the FDA PDUFA Date

2) “Indication” Column Link = Is the FDA Orphan Drug Product Designation Database Link.

Pomalyst is now in Phase III for both RRMM and for Myelofibrosis. Both the FDA and the European Medicines Agency (EMA) are reviewing applications for the approval of Pomalyst in combination with Dexamethasone for the treatment of RRMM patients who have received at least 2 prior therapies. Pomalyst belongs to the same class of drugs as Revlimid (Lenalidomide) and Thalomid (Thalidomide), which are 2 orphan drugs that Celgene already markets as MM treatments in the US and internationally.  Thus, Celgene currently has a strong presence in the MM market. Pomalyst will be extending the company’s leadership position in MM.

Here is a regulatory timeline for Pomalyst :

1)  January 15, 2003Receives FDA Orphan Drug Designation (ODD) for MM

2)  October 8, 2009Receives EMA orphan designation for MM

3)  May 2012 – A Marketing Authorization Application (MAA) is filed with EMA

4)  October 2012The November 8, 2012 FDA  Oncologic Drugs Advisory Committee (AdComm) Meeting for Pomalyst is cancelled.

At the December 8 – 11, 2012 Annual American Society of Hematology (ASH) Meeting in Atlanta, Georgia, Celgene presents data for orphan drug Pomalyst for the treatment of Multiple Myeloma (MM). The data Celgene presents on Pomalyst + Low-dose Dexamethasone from a Phase III Study, improves overall survival, progression-free survival, and overall response rate among very sick patients who failed either Revlimid or Velcade :

  1. Median progression-free survival (PFS) of 3.6 months for patients on Pomalyst and low-dose Dexamethasone compared with 1.8 months in a high-dose Dexamethasone arm
  2. “High statistically significant improvement in overall survival (OS) that crossed the upper boundary for superiority”
  3. Overall response rate was 21% compared with 3% in the control arm.

It is this Phase III data presented at the December 2012 ASH meeting that supports the pending application for RRMM with the EMA. The EMA decision is expected in 2013.

2013 Key Milestones for Pomalyst

1) 02/10/13 – US PDUFA date for RRMM

2) H1:13 – Phase III MF-002 data in Myelofibrosis

3) H2:13 – EU CHMP decision on RRMM

4) H2:13 – Submit sNDA for Myelofibrosis.

Multiple Myeloma Market

  1. Takeda’s orphan drug, proteasome inhibitor Velcade (Bortezomid) is the market leader, with > 60% share in 1st-line therapy & > 50% as a 2nd-line therapy
  2. Celgene’s orphan drug Revlimid is market leader with > 50% market share in front-line use
  3. Onyx Pharmaceuticals’ orphan drug, proteasome inhibitor Kyprolis (Carfilzomib) for Multiple Myeloma receives FDA approval in July 2012.

References 2012 article titled, ”Celgene’s Pomalidomide Helps in Myeloma after others fail”

Celgene Product Pipeline

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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