Urgent Market Withdrawal, Recall, Removal from Directory: Anti-cancer Innovative Drug Experiences Adverse Events

On the afternoon of March 9, 2026, around 5 p.m., Dài Qí, a patient with epithelioid sarcoma, suddenly received a call from the pharmacy informing him that the anti-tumor drug he was taking, hydrobromide Tazemetostat tablets, was being urgently recalled.

“I thought it was a scam call at first and was stunned.” Dài Qí had been taking this medication for six months and never expected that this innovative drug, which had been on the Chinese market for less than a year, would suddenly have issues.

Almost at the same time, Huarong Medicine (China) Co., Ltd. announced that the tumor treatment drug Dazemetostat (hydrobromide Tazemetostat tablets), authorized from Ipsen’s subsidiary Epizyme for introduction into China, had begun withdrawal and recall in mainland China, Hong Kong, and Macau, and all related clinical trials had been halted.

According to the drug voluntary recall report on Huarong Medicine’s official website, there was one batch of this drug on the market in China, involving 1,223 bottles, with 635 in stock and 588 sold; adverse events were only observed during clinical research, and no issues had been found during clinical use of the marketed product.

About an hour later, the National Healthcare Security Administration also issued a statement saying that from March 9, 2026, the hydrobromide Tazemetostat tablets would be removed from all provincial medical procurement platforms nationwide, and, upon company request, they would be removed from the 2025 “Commercial Health Insurance Innovative Drug List” (hereinafter referred to as the “Insurance List”).

Regarding this market withdrawal, a doctor from a top-tier hospital’s oncology department stated, “Seeing an ‘orphan drug’ that offers hope to rare disease patients being withdrawn due to potential risks, my first reaction was regret. However, given the serious potential risks, I fully understand the pharmaceutical company’s safety-based decision to withdraw. I hope there will be safer alternatives in the future.”

Epizyme’s announcement on hydrobromide Tazemetostat tablets. Epizyme official website / screenshot

Marketed in China for less than a year, urgently withdrawn due to adverse events

On March 9, Ipsen announced that it was working with the U.S. Food and Drug Administration (FDA) to withdraw hydrobromide Tazemetostat tablets, including indications for follicular lymphoma (FL) and epithelioid sarcoma (ES).

On the same day, in accordance with the “Drug Recall Management Measures” and related regulations, Epizyme and its domestic agent/authorized partner, Huarong Medicine, initiated withdrawal and recall procedures in China, with a Level 1 recall classification (use of the drug may cause serious health hazards).

According to Ipsen’s announcement, the voluntary recall was prompted by recommendations after an independent Data Monitoring Committee reviewed the latest data from ongoing SYMPHONY-1 Phase Ib/III studies. In treatments combining hydrobromide Tazemetostat with lenalidomide and rituximab for follicular lymphoma, secondary hematologic malignancies were observed as adverse events, suggesting that the potential risks of this treatment regimen may outweigh its benefits.

Secondary hematologic malignancies refer to blood cancers caused by other factors, not primary blood diseases. A study published in the journal Cancer Medicine indicated that for non-Hodgkin lymphoma (NHL) patients, chemotherapy, stem cell transplants, and radiotherapy are risk factors for secondary hematologic malignancies.

Ipsen also stated that, besides the market withdrawal, it would cease all ongoing clinical trials and expanded use programs for hydrobromide Tazemetostat.

According to Huarong Medicine’s disclosures, the company regularly summarized and reported the progress of recalls from patients, pharmacies, hospitals, and secondary distributors, locking and isolating the recalled products for supervised destruction.

On March 15, Southern Weekly contacted the relevant person responsible for the recall work, who declined to disclose details and asked to follow official channels for information.

In 2020, Epizyme’s hydrobromide Tazemetostat was granted accelerated approval by the FDA. In August 2021, Huarong Medicine announced a partnership with Epizyme to conduct research, development, manufacturing, and commercialization of the drug in Greater China.

In March 2025, the drug received conditional approval from China’s National Medical Products Administration (NMPA) for treating adult patients with relapsed or refractory follicular lymphoma with EZH2 mutations after at least two prior systemic therapies.

About 27% of follicular lymphoma patients in China have acquired EZH2 mutations. Currently, two EZH2 inhibitors have been approved domestically: the withdrawn hydrobromide Tazemetostat and Zemetostat developed by Hengrui Medicine for relapsed or refractory peripheral T-cell lymphoma.

In December 2025, hydrobromide Tazemetostat was included in the first edition of the Commercial Insurance List. At the 2025 High-Quality Development Conference for Innovative Drugs, Zhang Ke, Secretary of the Party Leadership Group and Director of the National Healthcare Security Administration, presented certificates to representatives of 18 companies whose drugs were selected (see Southern Weekly’s article “19 high-priced drugs included: How will the first edition of the Commercial Insurance List for innovative drugs be implemented?”).

Less than a year after its domestic launch and only three months after being included in the insurance list, this star drug was urgently withdrawn due to adverse events.

Dai Qi, a young man born in the 1990s, was diagnosed with epithelioid sarcoma in 2023, a rare malignant tumor classified as a second-tier rare disease in China. In October of that year, he underwent his first surgery, but in June 2024, the tumor recurred, leading to a second, more extensive surgery. After over a year of combined radiotherapy and other medications, he relapsed again in August 2025, and “had to continue with more surgery, undergoing a third operation.”

Following his doctor’s advice, he started taking hydrobromide Tazemetostat tablets and underwent chemotherapy simultaneously. “Because the target of this drug matches my epithelioid sarcoma quite well, I’ve been taking it for six months. From the check-up results, I’m recovering pretty well so far.”

Dai Qi said that after being notified of the recall on the evening of March 9, he immediately asked his doctor, “The doctor advised me to switch to another EZH2 inhibitor.”

Launched in less than a year, $2.5 million in sales

EZH2 methyltransferase inhibitors are a class of epigenetic targeted drugs that inhibit the activity of EZH2 methyltransferase, blocking tumor-related gene silencing for targeted cancer therapy.

As the world’s first EZH2 inhibitor, hydrobromide Tazemetostat was approved for accelerated listing by the FDA in 2020. This innovative drug was also hoped to become a new treatment option for patients with epithelioid sarcoma and relapsed/refractory follicular lymphoma in China.

Lymphoma is one of the common malignant tumors in China, with non-Hodgkin lymphoma (NHL) accounting for about 90% of all lymphomas. The China Cancer Report 2022 from the National Cancer Center states that in 2022, there were approximately 85,200 new cases of lymphoma and about 41,600 deaths, ranking 13th in new cancer cases and 12th in cancer deaths nationwide.

Follicular lymphoma, originating from follicular center B cells, is a common indolent non-Hodgkin lymphoma that currently cannot be cured completely. Most patients face repeated relapses.

Hydrobromide Tazemetostat has been included in the CSCO Lymphoma Diagnosis and Treatment Guidelines 2024 as a recommended second-line, third-line, or subsequent treatment for relapsed/refractory follicular lymphoma.

According to Huarong Medicine, in 2025, Dazemetostat’s market sales reached $2.5 million, a 158% increase from $900,000 in 2024.

Hong Fei, founder of the patient organization “Lymphoma Home,” explained that among the 160,000 patients in the group, about 6% have follicular lymphoma. “Most are well-controlled with first- or second-line treatments, so only a small number of patients really need this new drug.”

Hong Fei believes that the market withdrawal has limited impact on the overall patient population. “Follicular lymphoma is a long-term disease; losing one drug doesn’t make a big difference.”

Epithelioid sarcoma is a rare, highly malignant mesenchymal tumor prone to recurrence and lymph node metastasis, accounting for less than 1% of all soft tissue sarcomas.

On July 10, 2025, the Diagnosis and Treatment Guidelines for 86 Rare Diseases (2025 Edition) issued by the National Health Commission recommended hydrobromide Tazemetostat for treating patients over 16 years old with unresectable metastatic or locally advanced epithelioid sarcoma who are not suitable for complete resection.

Dai Qi said that because his indication is not covered by the insurance list, he has to pay out of pocket. “One bottle is enough for a month, costing over 30,000 yuan per bottle, about 1,000 yuan a day. I’ve been looking for reimbursement channels.” On March 1, 2026, he applied to join a patient charity program for this drug, which could reimburse part of the cost.

But shortly after the program started, he received notice from the pharmacy that the drug was being recalled and withdrawn.

“On March 6, my reimbursement application was still pending, and I was quite surprised. I didn’t know the reason. Then on March 9, my reimbursement was canceled, and the whole project basically ended.” Dai Qi said, “I think this drug is effective, but now it’s recalled, and I have nowhere to buy it.”

“I haven’t seen official data on how much this affects patients, but I believe regulatory agencies will have higher safety standards.” Hong Fei said that for some resistant (follicular lymphoma) patients, “what they care about most is whether they can achieve long-term remission with EZH2 inhibitors.”

Southern Weekly sent inquiries on March 10 about the clinical trial data and adverse event rates to Ipsen’s public affairs and corporate communication department. As of press time, no reply had been received.

(At the patient’s request, Dai Qi is a pseudonym.)

Southern Weekly Special Contributor Liu Shijun

Editor: Huang Sizhuo