BMS Pharmaceutical Korea has obtained permission for a series of blood cancer treatments this year, increasing its weight in the domestic market.
Starting with a nod for the treatment of acute myeloid leukemia, Onureg (azacitidine), in March, it obtained approvals for Inreㅠic (pedratinib), a treatment for myelofibrosis, in April, and for Reblozyl (luspatercept), a treatment for myeloid dysplasia, in May.
Also, the company said it was making every effort to introduce CAR-T (Chimeric Antigen Receptor-T cell) therapies, which marked a milestone in the history of blood cancer treatment, such as Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel).
BMS Korea General Manager Lee He-young unveiled new pipelines to be introduced in the Korean market at a recent news conference with reporters covering multinational pharma companies
CEO Lee is a healthcare specialist who has developed business and accumulated various functional experiences, such as strategy and marketing at Pfizer, Viatris, and Roche, for about 25 years. Most recently, she served as the country manager of Viatris Korea, spun off from Pfizer, and was appointed as the general manager of BMS Pharmaceutical Korea on Aug. 10
“Beginning with the merger of Celgene in 2019, BMS has acquired MyoKardia and Turning Point Therapeutics, doubling its pipelines and is conducting research on more than 50 new drug candidate substances for about 40 diseases,” Lee said. “Brystol Myers Squibb has grown to the sixth-largest biopharmaceutical company worldwide with annual sales of about $46 billion (67 trillion won).”
As Lee explained, BMS acquired Celgene at $74 billion in 2019. Industry executives said at the time that BMS, which possessed the first immuno-cancer drugs, like Yervoi and Opdivo, and has strengths in solid and skin cancer, secured an opportunity to further enhance its development capabilities in the field of anti-tumor by merging Celgene specialized in blood cancer.
Responding to such expectations, BMS drew attention by developing two CAR-T treatments that made a new history in the blood cancer treatment – Breyanzi, approved as a treatment for large B-cell lymphoma, and Abecma, approved as a treatment for recurrent and refractory multiple myeloma.
Introducing BMS’s blood cancer pipelines under the spotlight, Country Manager Lee said, “Currently, there are Revlimid, Sprycel, and three more that additionally won approvals this year – Onureg, Inrebic, and Reblozyl. Besides, two types of CAR-T treatments approved by the U.S. Food and Drug Administration receive high expectations. BMS is the only company in the industry with two CAR-T treatment types.
However, she stopped short of elaborating on introducing the two CAR-T treatments to Korea.
"Unlike other treatments, there are many things to consider and prepare for introducing CAR-T treatments, so it takes some time,” Lee said. “One encouraging fact is that a clinical trial of one of the CAR-T treatments is planned in Korea. We expect experiences accumulated during the clinical trial to help us introduce CAR-T treatments in the future.”
Novartis's Kymriah (tisagenlecleucel) is the only CAR-T treatment approved in Korea. Kymriah is approved for treating recurrent, refractory B-cell acute lymphoblastic leukemia and recurrent, refractory giant B-cell lymphoma. However, in the case of giant B-cell lymphoma indication, it can only be used in tertiary or higher cases that have failed in two or more systemic treatments.
In contrast, Breyanji can be used in patients who don’t respond to the first chemotherapy, those who experience recurrence within 12 months of the initial chemotherapy, and those who cannot conduct hematopoietic stem cell transplantation (HSCT) due to accompanying disease or age, emerging as the treatment option applicable to the broadest range of patients among CAR-T treatments.
Introducing CAR-T treatments requires not just approvals but also additional efforts on the part of pharmaceutical companies, including certifications by medical institutions that can provide CAR-T treatments and the training of medical workers. That explains why experts say pharmaceutical companies’ intention plays an important part in introducing CAR-T treatments.
It also causes concerns among industry officials about whether BMS Korea intends to introduce Breyanji or Abecma.
In response, Lee said, “As the country manager of BMS Korea, I have great interest in the swift introduction of CAR-T treatments to Korea and have been continuously examining the possibility of their market launch. In the case of CAR-T treatments, there are many things to consider, including manufacturing and distribution. However, I expect the upcoming domestic clinical trials to be a good opportunity to obtain related know-how.”
Besides, Lee emphasized that many blood cancer treatments of BMS Korea are already playing an important role in Korea.
“BMS Korea has already introduced and supplied many treatments in the area of blood cancer,” Lee said. “For example, we have introduced Revlimid, a treatment for multiple myeloma, and Sprycel, a treatment for chronic myeloma leukemia. In addition, we will release three more newly approved treatments, offering treatment options to many more patients in the blood cancer area, a severe blood disease.”
More specifically, BMS has received approval for Inrebic to treat myelofibrosis with no secondary treatment option and Onureg for acute myelogenous leukemia. In addition, Reblozyl won the nod for a treatment for a condition called myeloid dysplasia or myeloid dysplasia in patients with no alternative but blood transfusions as a promoter for red blood cell production, Lee added.
“Because Reblozyl reduces the demand for blood transfusions, I think it will help in areas, such as blood supply and demand concerning the domestic blood transfusion environment after Covid-19,” she said.
However, the reimbursements for the three blood cancer treatments have not been decided yet.
“As all the treatments’ indications are diseases with high unfulfilled demands, they aim to increase patient access,” Lee said. “However, there will be various problems until they get insurance benefits, and we need to seek new ideas to overcome them.”
Now that the government has announced that it would strengthen patient coverage for rare severe diseases, the parties involved need to discuss details with an open mind, Lee noted.
“We will launch these treatments (regardless of whether they get insurance benefits or not) and are looking for various ways to help patients even before entering the reimbursable territory,” she added.