Expanded reimb for 'Zejula'

"It will be used more widely in clinical practices"

The long-term treatment over 6 years demonstrated consistent benefits in efficacy·safety

Has an advantage as once-daily oral administration…can be used widely in clinical practices

Dr.

 

Jae-Weon Kim of Seoul National University Hospital

Following the reimbursement expansion of Zejula for ovarian cancer, patient access to treatment has been improved.

 

Experts suggest that Zejula will be more widely used in clinical practices based on demonstrated benefits in efficacy and safety in long-term treatment studies.

 

On January 16, Takeda Pharmaceutical Korea held a press conference commemorating the reimbursement expansion of Zejula monotherapy as a first-line maintenance therapy of HRd-positive ovarian cancer.

 

As of October 2024, the national health insurance reimbursement criteria for Zejula have been expanded to include treatment of homologous recombination deficiency (HRD)-positive ovarian cancer.

 

Previously, Zejula has been covered by reimbursement only as a maintenance therapy for the first-line treatment of patients with ovarian cancer associated with BRCA who respond to platinum-based therapy.

 

Due to the reimbursement expansion, Zejula became the only PARP (Poly ADP-ribose Polymerase)-inhibitor covered by reimbursement for the first-line maintenance therapy used in patients with HRd-positive ovarian cancer.

 

HRd refers to homologous recombination deficiency, a DNA damage repair mechanism.

 

When HRd is positive, cancer cells cannot efficiently repair DNA damage.

 

It is particularly associated with BRCA1/2 gene mutations frequently observed in breast and ovarian cancers.

 

Experts suggest that the clinical prevalence of HRd expression in ovarian cancer is over 50%.

 

Based on a long-term follow-up study of 6.2 years, Zejula demonstrated significant benefits for patients with HRd-positive ovarian cancer.

 

In the clinical study, the HRd patient group treated with Zejula recorded a progression-free survival of 24.5 months, which was markedly different from the 11.2 months of the placebo group.

 

At the five-year mark of treatment, the number of patients who survived without disease progression in the Zejula group was twice as high as that in the placebo group.

 

In the HRd patient group, a statistically significant difference in progression-free survival was observed between those treated with Zejula and those given a placebo up to five years of treatment.

 

"Zejula has demonstrated long-term PFS benefits through the PRIMA trial, its approval study, and follow-up studies.

 

In terms of safety, adverse events were consistent with previous clinical results, confirming its safety even with long-term use," Dr.

 

Jae-Weon Kim of Seoul National University Hospital's Department of Obstetrics and Gynecology stated.

 

In clinical practices, prescriptions for Zejula have been increasing since its reimbursement expansion.

 

Ovarian cancer patients take two 100 mg tablets once daily, while Zejula is the only ovarian cancer treatment available with a once-daily dosing regimen.

 

"Since the reimbursement expansion notice, no severe adverse events have been reported among HRd-positive patients continuing first-line maintenance therapy with Zejula monotherapy.

 

Zejula, as an oral medication administered once daily, significantly enhances patient convenience," Dr.

 

Jung-Yun Lee of Severance Hospital's Department of Obstetrics and Gynecology emphasized.

 

Dr.

 

Lee added, "HRd is a biomarker commonly observed during first-line maintenance therapy.

 

With the reimbursement expansion of Zejula, there has been an increase in cases involving HRd testing, leading to higher diagnosis rates.

 

Through diagnostic testing, many patients are expected to benefit from Zejula."

Dr.

 

Jung-Yun Lee of Severance Hospital