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Celgene: FDA approval of POM “based on response rate.”

Posted on February 08 2013 by Pat Killingsworth | 1,209 views

Here’s Celgene’s official press release about today’s FDA approval of pomalidomide.  I will review what the news means to me–and my fellow patients and caregivers–this weekend.

U.S. FOOD AND DRUG ADMINISTRATION APPROVES POMALYST® (POMALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA

Celgene logoSUMMIT, NJ – (Feb. 8, 2013) – Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved POMALYST® brand therapy (pomalidomide) for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Supporting the approval were the results of MM-002, a phase II, randomized, open-label study evaluating pomalidomide (4 mg once daily on days 1-21 of each 28-day cycle) plus low-dose dexamethasone (40 mg per day given only on Days 1, 8, 15 and 22 of each 28-day cycle for patients 75 years or younger, or 20 mg per day given only on Days 1, 8, 15 and 22 of each 28-day cycle for patients greater than 75 years of age) versus pomalidomide (4 mg once daily on days 1-21 of each 28-day cycle) alone in patients with relapsed multiple myeloma who were refractory to their last myeloma therapy and had received lenalidomide and bortezomib.

Of the 221 patients that were evaluable for response, 29.2% (95% CI 21.0, 38.5) achieved a partial response or better in the pomalidomide plus low-dose dexamethasone arm compared to 7.4% (95% CI 3.3, 14.1) in the pomalidomide-alone arm. Overall Response Rate was based on responses assessed by the Independent Review Adjudication Committee (IRAC) based on the European Group for Blood and Marrow Transplantation (EMBT) criteria. The median duration of response for patients in the pomalidomide plus low-dose dexamethasone arm was 7.4 months (95% CI 5.1, 9.2) while the median has not yet been reached for the pomalidomide alone arm.

POMALYST is an analogue of thalidomide, is contraindicated in pregnancy and is only available through a restricted distribution program called POMALSYT REMS.TM Deep venous thrombosis (DVT) and pulmonary embolism (PE) occur in patients with multiple myeloma treated with POMALYST. Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

In the study, 219 patients were evaluable for safety. The most common grade 3 or 4 adverse reactions (≥15%) in the pomalidomide plus low-dose dexamethasone arm versus pomalidomide alone respectively, were neutropenia (38% and 47%), anemia (21% and 22%), thrombocytopenia (19% and 22%), and pneumonia (23% and 16%).

POMALYST will only be available in the United States through POMALYST REMS,™ a restricted distribution program.

POMALYST® is a registered trademark of Celgene Corporation

About POMALYST®

POMALYST® oral therapy comprises pomalidomide, an IMiDs® compound. POMALYST and other IMiDs compounds continue to be evaluated in over 100 clinical trials.

POMALYST® (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

It’s unclear why this particular study was featured.  There are others with much better numbers.  Note also that the FDA only approved pom to be used in a relatively small subset of patients, “who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.”

Of course doctors can and will start using the drug “off label” immediately.  Don’t be surprised to start hearing about myeloma specialists that are prescribing the new “dream team” as a combination therapy: Kyprolis, POMALYST and dex.

More to follow, including links to important POM studies and anectodal evidence that supports the argument that pomalidomide may be the most effective multiple myeloma therapy agent developed to date–that is until Millennium’s oral proteasome inhibitor, MLN9708 is approved in a year or two.

Feel good, keep smiling and make sure you pay your insurance and Medicare premiums on time; Kyprolis and POM aren’t cheap!  Pat

7 Comments For This Post

  1. Pam Says:

    I understand this might now be the best drug compared to Kyprolis but I can’t help but think of all the people in the studies that make new drugs happen for us. Right this second and forever more they will be in my prayers to the universe. In my mind these people have exhausted all options for treatment and instead of saying “I’ve had enough” they’ve been brave enough to endure who knows what side effects and possibly poor quality of life to ensure that more is learned about our disease and new treatment options are made available. Bless them all.

  2. Pat Killingsworth Says:

    Amen. Amen…

  3. Nancy Shamanna Says:

    I am very glad to know that pomalidimide is approved now in the US. I am sure it will help a lot of patients, and give another option for treatment. Hope that Celgene also applies soon for it’s approval in Canada…there are lots of really ill myeloma patients here too! Also, I agree that we should always remember the ones who tried out these drugs in order to bring them to a safe situation for approval.

  4. Judy Malkiewicz Says:

    I was approved for pomalidomide (Pomalyst) 4 mg with dex 40 mg on 4 Mar 2013 for a relapse while on carfilzomib/dex 24 mg/ revlimid 10 mg 21/28 days with a bone marrow plasma cell count at 60% – up from 40% 2 months prior on 20 Dec 2012 while on carfilzomib/dex 24 mg/revlimid 10 mg 21/28 days and cytoxan 500 mg which had to be stopped after 2 weeks because of low blood counts.
    I have non-secretory high risk multiple myeloma with 4:14, 1q changes, and MANY others and have to be followed by bone marrow biopsy as my SPEP tests are not reflective of my disease – I’ve had 10 BMB’s since diagnosis May 2011.
    I have had 2 failed autologous stem cell transplants. While I have been in relapse for the whole of the last year, I doing pretty well clinically. I have NO kidney, bone disease, or infections (other than easily treated sinus infections) and I have NEVER been re-hospitalized after my stem cell transplants.
    My main problems are with low wbc, low ANC, low hemoglobin, low platelets, GASTRITIS and decreased energy levels, but I have been able to drive myself to my chemo and oncologist appointments 135 miles each way weekly, as I live in rural Idaho. I live my public life in a N-95 mask.
    So, pomalidomide approved by the FDA on 8 Feb 2013 is just in time for me! I HOPE. Judy Malkiewcz, Mackay, Idaho

  5. Pat Killingsworth Says:

    So great hearing from you, Judy. I so hope POM is the answer for you! Pattie and I are keeping our fingers crossed…

  6. Dean Satchwell Says:

    Judy, I to live in Idaho and travel 150 miles for treatment. I am in Bonners Ferry, near the Canadian border and travel to Spokane. I am starting POM today, waiting for FedEx to arrive with it. I hope it works for you and me too, along with everyone else.
    Pat thank you so much for coming to Spokane and talking to our N. Idaho-E. WA support group. My wife and I enjoyed you very much.

    Dean, Bonners Ferry, ID

  7. Pat Killingsworth Says:

    Sorry our system “lost” Dean’s comment from last week. Thanks for reading, Dean…

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