FDA

FDA approves Pomalyst for advanced multiple myeloma

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration has approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease.

Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory).

"Pomalyst is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Treatment for multiple myeloma is tailored to meet individual patient's needs, and today's approval provides an additional treatment option for patients who have not responded to other drugs."

In July 2012, FDA approved Kyprolis (carfilzomib) to treat multiple myeloma. Similar to Kyprolis, Pomalyst is being approved under the agency's accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug's clinical benefit and safe use. The therapy was also granted orphan product designation because it is intended to treat a rare disease or condition.

Pomalyst's safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma. The trial was designed to measure the number of patients whose cancer completely or partially disappeared after treatment (objective response rate, or ORR). Patients were randomly assigned to receive Pomalyst alone or Pomalyst with low-dose dexamethasone, a corticosteroid.

Results showed 7.4 percent of patients treated with Pomalyst alone achieved ORR. The median duration of response has not yet been reached in these patients. In patients treated with Pomalyst plus low-dose dexamethasone, 29.2 percent achieved ORR with a 7.4-month median duration of response.

Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots.

Because of Pomalyst's embryo-fetal risk, it is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients who are not pregnant but can become pregnant must comply with the pregnancy testing and contraception requirements, and males must comply with contraception requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Common side effects include a decrease in infection-fighting white blood cells (neutropenia), fatigue and weakness, low red blood cell count (anemia), constipation, diarrhea, low levels of platelets in the blood (thrombocytopenia), upper respiratory tract infections, back pain and fever.

Pomalyst, lenalidomide and thalidomide are marketed by Celgene, based in Summit, N.J. Kyprolis is marketed by South San Francisco, Calif.-based Onyx Pharmaceuticals.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Boehringer Ingelheim increases acce…

Boehringer Ingelheim is announcing an expansion of its Intellectual Property (IP) enforcement policy. The IP enforcement policy had already been amended in 2007 by an eas...

Read more

AstraZeneca licenses Zurampic to Gr…

AstraZeneca today announced that it has entered into a licensing agreement with Grünenthal GmbH for the exclusive rights to Zurampic (lesinurad) in Europe and Latin Ameri...

Read more

Exercise, future anticancer therapy…

Several studies have demonstrated the benefits of exercise to improve the quality of life of people with cancer. But Dr. Fred Saad, urologist-oncologist and researcher at...

Read more

Merck announces survey results expl…

Merck, a leading science and technology company, today announced survey results of 250 global biopharmaceutical executives on how their companies will manage new risks as...

Read more

Pfizer presents promising data from…

Pfizer Inc. (NYSE:PFE) today announced encouraging new data from a Phase 1/2 study of lorlatinib, the proposed generic name for PF-06463922, Pfizer's investigational, nex...

Read more

Promising treatment prospects for i…

In Switzerland alone, more than 5,700 women are diagnosed with breast cancer each year, and almost 1,400 of those affected die of the disease. In many very invasive forms...

Read more

Bayer Science & Education Found…

Applications for the Bayer Science & Education Foundation's international scholarship programs are now being accepted for this year's round. In the academic sector, ambit...

Read more

Merck Accelerator expands its reach…

Merck, a leading science and technology company, has started this week the application period for the next round of its Accelerator programs in Darmstadt, Germany, and Na...

Read more

Boehringer Ingelheim and Harvard sc…

Boehringer Ingelheim today announced it has established a research collaboration with the Harvard Stem Cell Institute's - Harvard Fibrosis Network to discover new ways of...

Read more

New class of protein could treat ca…

A protein designed by researchers at Georgia State University can effectively target a cell surface receptor linked to a number of diseases, showing potential as a therap...

Read more

AstraZeneca enters commercialisatio…

AstraZeneca today announced it has entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anae...

Read more

Call for Abstracts: DIA EuroMeeting…

29 - 31 March 2017, Glasgow, UK. The DIA EuroMeeting 2017 provides a platform for experts from all relevant disciplines within the entire healthcare development and acce...

Read more

Digest World Pharma Newsletter

Subscribe to our weekly Digest World Pharma Newsletter and stay updated on the latest World Pharma News. Subscribe now, it's free!

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]