Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).
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| [13-February-2024] |
| KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection). ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.i Multiple myeloma, commonly referred to as myeloma, is an aggressive, currently incurable, type of blood cancer that affects plasma cells made in the bone marrow.ii “Multiple myeloma is a disease of high unmet need as patients relapse and become refractory to successive and limited therapies,” said Dr. Richard LeBlanc, hematologist at Hôpital Maisonneuve-Rosemont. “The approval of ELREXFIO is good news for patients and their healthcare teams as it offers a new treatment possibility for those living with the disease.” Multiple myeloma is the second-most common type of blood cancer, with an estimated 11 Canadians being diagnosed with myeloma every day.iii It is estimated that in 2023, 3,900 Canadians were diagnosed with multiple myeloma and 1,700 Canadians died from the disease.iv “Multiple myeloma can be an incredibly challenging cancer to live with and manage,” said Martine Elias, Executive Director at Myeloma Canada. “When it comes to treating myeloma, each case must be assessed individually. What works for one patient may not work for another. This is why it’s so important that people living with the disease have access to many and new options even more so when they have relapsed.” About Relapsed or Refractory Multiple Myeloma Multiple myeloma is associated with the abnormal behavior and uncontrolled growth of the plasma cells. In people with multiple myeloma, abnormal plasma cells crowd out other types of blood cells. As a result, a person can become anemic, bleed easily and have increased susceptibility to infection.v Other symptoms of multiple myeloma may include frequent infection; fatigue or shortness of breath; numbness or weakness; low platelet, red or white blood cell counts; or bone problems including pain, weakness or fractures.vi,vii While disease trajectory for myeloma varies for each person, relapses are nearly inevitable, and many people become resistant to treatments – these people have what is referred to as relapsed and refractory multiple myeloma.viii There is no cure for multiple myeloma and most patients living with multiple myeloma will receive four or more lines of therapy due to relapse.ix “At Pfizer we are dedicated to developing innovative therapies that can help improve outcomes for patients,” said Cynthia Di Lullo, Oncology Business Lead, Pfizer Canada. “We are immensely proud that we can offer a new treatment option for patients living with multiple myeloma in Canada.” About ELREXFIO ELREXFIO is a subcutaneously delivered BCMA-CD3-directed bispecific antibody (BsAb). ELREXFIO binds to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill the myeloma cells. Health Canada’s review of ELREXFIO was conducted under Project Orbis, a framework for the concurrent submission and review of oncology drugs among international partners to potentially expedite approvals. Concurrently 5 countries (US, Canada, Switzerland, Brazil, Australia, and Singapore) participated. ELREXFIO is currently approved in the US, Switzerland, Brazil and Canada. ELREXFIO was approved based on clinically meaningful response rates and duration of response from a single-arm phase 2 study. In line with the NOC/c authorization for ELREXFIO, Pfizer will continue its clinical development program investigating ELREXFIO’s use across the entire spectrum of myeloma progression, from newly diagnosed multiple myeloma to RRMM. Supply of ELREXFIO is now available in Canada. For more information, please consult the ELREXFIO Product Monograph at www.pfizer.ca. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world’s leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, X, Instagram or YouTube.
SOURCE Pfizer Canada |