Bristol Myers Squibb Submits NDA for Pomalidomide Capsules in China

China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has announced that Bristol-Myers Squibb Company (BMS) has submitted a marketing application for the Class 5.1 new drug Pomalidomide Capsules, which has been accepted. Public information indicates that Pomalidomide is an immunomodulatory drug developed by Celgene, a subsidiary of BMS. It has previously been approved overseas for use in multiple myeloma and Kaposi's sarcoma. According to data from the BMS company website, the drug achieved global sales of $3.3 billion in 2021, demonstrating its significant clinical demand.

Screenshot source: CDE official website

Pomalidomide (generic name: pomalidomide, brand names: Pomalyst/Imnovid) is a thalidomide analog and belongs to the class of immunomodulatory drugs. It has multiple mechanisms of action and can inhibit the proliferation of hematologic tumor cells while inducing apoptosis. The drug was first approved by the U.S. FDA in 2013 for use in combination with dexamethasone to treat patients with multiple myeloma (MM) who have previously received at least two prior therapies, including lenalidomide and proteasome inhibitors, and have demonstrated disease progression within or after 60 days of completing their last treatment.

Multiple Myeloma: A Common Hematologic Malignancy Characterized by Repeated Remissions and RelapsesMultiple myeloma is a common hematologic malignancy characterized by repeated remissions and relapses. Over time, this disease gradually develops resistance to various therapies, becoming refractory. Public data shows that pomalidomide can effectively treat multiple myeloma at lower doses, significantly reducing the risk of adverse drug reactions. Moreover, it demonstrates good efficacy in patients who are refractory to both lenalidomide and bortezomib.

In May 2020, pomalidomide received another FDA approval for the treatment of Kaposi sarcoma patients associated with AIDS who are resistant to antiretroviral therapy (HAART), as well as HIV-negative Kaposi sarcoma patients. Public information indicates that this is the first new treatment option for Kaposi sarcoma patients in over 20 years. This accelerated approval was based on positive results observed in a phase 1/2 open-label single-arm clinical trial (12-C-0047). The data showed that for all subjects treated with pomalidomide, the objective response rate (ORR) was 71%, with a median duration of response of 12.1 months.

Kaposi's sarcoma is a rare cancer caused by infection with Kaposi's sarcoma-associated herpesvirus, also known as human herpesvirus 8. Kaposi's sarcoma is more common in people infected with HIV. HIV-positive patients who are resistant to or unable to tolerate systemic chemotherapy have no other approved treatment options, so there is an urgent need for innovative therapies to treat this disease in these patients. The emergence of pomalidomide provides an oral therapy for such patients, and it has shown positive results in Kaposi's sarcoma patients regardless of their HIV infection status.

In addition to the approved indications, Bristol-Myers Squibb Company is also exploring other indications for pomalidomide globally, such as lymphoma, AL amyloidosis, pediatric glioblastoma, etc., and some trials have entered Phase 2 clinical stage.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Jun 3, 2022. From https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Pomalyst. From https://packageinserts.bms.com/pi/pi_pomalyst.pdf

[3] U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst® (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma. Retrieved 2020-05-15, from https://www.businesswire.com/news/home/20200515005277/en

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