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Curocell's Anbal-cel (brand name: Rimqarto), a locally developed CAR-T therapy, has been designated by the government for expedited approval and market launch through a simultaneous process of domestic approval, coverage evaluation, and drug price negotiation.
Curocell's headquarters in Daejeon (Courtesy of Curocell)
Curocell's headquarters in Daejeon (Courtesy of Curocell)
Curocell said Tuesday that its next-generation CAR-T therapy, Anbal-cel, has been selected as the second target drug for the Ministry of Health and Welfare's “Approval application, reimbursement assessment, and drug price negotiation pilot project.”
“We will provide faster treatment opportunities for patients with severe hematologic cancers by simultaneously applying for approval from the Ministry of Food and Drug Safety (MFDS), evaluating coverage, and negotiating drug prices,” Curocell said.
Anbal-cel is a next-generation CAR-T therapy for patients with relapsed or refractory large B-cell lymphoma (LBCL). It demonstrated excellent efficacy and a favorable safety profile, with a 67.1 percent complete response rate at the end of the phase 2 trial.
Curocell said it completed its application for the second pilot project in August based on the following criteria:
ㆍA drug that can apply for approval and decision by the end of June next year
ㆍ A drug with sufficient efficacy for the treatment of a life-threatening disease or rare disease
ㆍ A drug for which there is no existing treatment or that shows a clinically meaningful improvement over existing treatments
ㆍ A drug that is designated or eligible for the Ministry of Food and Drug Safety's Global Innovative Product Fast Track (GIFT) system
The Health and Welfare Ministry is implementing the pilot project with the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) to improve patient access to expensive drugs for serious diseases and strengthen efficiency in benefits management.
Through this pilot project, the drug payment process of MFDS approval, HIRA’s reimbursement assessment, and NHIS’ drug price negotiation have been improved so that drug price negotiation is completed at the same time as the MFDS approval. That shortens the process, which previously took more than 300 days, including 120 days for MFDS’ approval, 150 days for HIRA’s reimbursement evaluation, and 60 days for NHIS’ drug price negotiation.
Ten products were applied for the second pilot project -- five anticancer drugs and five rare disease drugs, including Anbal-cel. The Health and Welfare Ministry selected three out of the 10 drugs as the second round of the program after comprehensively considering the severity of the disease, availability of alternative drugs, urgency, treatment effectiveness, and expert opinions.
Notably, Curocell is the only domestic manufacturer of the selected drugs. The rest of the companies are leading global multinational pharmaceutical companies, making it even more meaningful for the domestic bio startup to stand shoulder to shoulder with global big pharma, Curocell said.
“The selection of Anbal-cel for the second round of the parallel approval-assessment-negotiation pilot project is an important opportunity to realize the innovative potential of CAR-T therapy for patients with advanced LBCL who have no alternative treatment,” Curocell CEO Kim Gun-soo said. “We will continue to work with the health authorities to improve access to treatment and focus all our efforts on providing practical help to patients and to develop innovative therapies to protect the lives and health of patients.”
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Kim Kyoung-Won kkw97@docdocdoc.co.kr
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Tagrisso (osimertinib), a targeted therapy, has received approval for treating patients with unresectable stage 3 EGFR-mutated (Ex19del, L858R substitution) non-small cell lung cancer (NSCLC) whose disease has not progressed during or after platinum-based chemotherapy and radiation therapy for which there are no targeted therapy options.
AstraZeneca’s lung cancer treatment Tagrisso (Courtesy of AstraZeneca Korea)
AstraZeneca’s lung cancer treatment Tagrisso (Courtesy of AstraZeneca Korea)
AstraZeneca Korea said it received an expanded indication from the Ministry of Food and Drug Safety (MFDS) for Tagrisso to treat EGFR-mutant NSCLC last Friday.
That allows Tagrisso monotherapy to be used for treating patients with unresectable locally advanced NSCLC who have an EGFR exon 19 deletion or exon 21 (L858R) substitution and whose disease has not progressed during or after platinum-based chemotherapy and radiotherapy.
In addition, Targriso is approved in Korea for the first-line treatment of patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 substitution.
ㆍ For combination with pemetrexed and platinum-based chemotherapy in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or exon 21 substitutions.
ㆍ For combination with pemetrexed and platinum-based chemotherapy in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or exon 21 substitution.
ㆍ For treating patients previously treated with an EGFR- TKI in treating patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC who have been previously treated with an EGFR- TKI.
ㆍ For adjuvant treatment after complete tumor resection in patients with EGFR exon 19 deletion or exon 21 substitution mutated NSCLC, it is the broadest indication for a targeted therapy in EGFR-mutated NSCLC.
The study (LAURA) that supported this indication expansion was a randomized, double-blind, placebo-controlled, multicenter, global phase 3 trial in patients with unresectable stage 3 EGFR-mutant NSCLC whose disease had not progressed after platinum-based chemotherapy and radiation therapy.
Results showed that Tagrisso reduced the risk of disease progression or death by 84 percent compared to placebo. Median progression-free survival (mPFS) in the Tagrisso arm was 39.1 months, 33.5 months longer than placebo (5.6 months). In addition, safety and tolerability were similar to the safety profile of each prior treatment, with no new safety concerns identified.
“The LAURA trial demonstrated a progression-free survival of 39.1 months in the Tagrisso arm, confirming a survival benefit of more than three years,” said Professor Kim Hye-ryun of the Department of Medical Oncology at Severance Hospital. “With this approval, patients with unresectable stage 3 EGFR-mutant NSCLC who have not had a targeted therapy option before can benefit from Tagrisso. The drug sets a new standard for treating unresectable stage 3 EGFR-mutant NSCLC.”
Lim Jae-yun, executive vice president for medical affairs at AstraZeneca Korea, said, “This indication expansion allows patients with all stages of EGFR-mutant NSCLC to benefit from Targriso. It will further solidify Tagrisso's value as a backbone treatment for EGFR-mutant NSCLC. We will continue to build on Tagrisso's innovative therapeutic value to improve survival and quality of life for patients with EGFR-mutant NSCLC.”
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Kim Kyoung-Won kkw97@docdocdoc.co.kr
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