Yuhan Corp. is drawing the industry’s attention by sharply improving patient access to its new lung cancer drug Leclaza (lazertinib), through an expanded access program (EAP).

According to medical sources, the first and second patients prescribed Leclaza free of charge through EAP have been registered with Kosin University Gospel Hospital in Busan recently.

EAP provides free supplies of specialized drugs for compassionate purposes after they win approval for the market until they can be prescribed in the clinical field. However, it must undergo a review and win approval from the institutional review board (IIRB) in each medical institution.

Biopharma industry officials believe the number of patients receiving EAPs to increase gradually.

Leclaza won approval from the Ministry of Food and Drug Safety last month as a first-line treatment for non-small cell lung cancer (NSCLC).

At a news conference early this month, Yuhan said it would supply Leclaza free of charge until it gets reimbursement as the first-line treatment. The company added that it would not limit the number of medical institutions (secondary and tertiary) or patients, explaining that the decision was made to inherit the spirit of its deceased founder, Dr. Yu Il-han.

The EAP-applied Leclaza is available to all patients with locally progressive or metastatic NSCLC with EGFR exon 19 deletion (Exon19del) or exon 21 (L858R) substitution mutations, who have not received prior therapy and are eligible for first-line indications.

"As shown by public petitions posted, there were many patients who wanted to be treated with EGFR third-generation lung cancer therapies but were unable to do so due to their financial situation," said Kim Yeol-hong, president for R&D at Yuhan, at the news conference. "Yuhan Corp. gives back part of what it has to society in the spirit of the late Dr. Yu Il-han, which explains why we made this decision upon winning the approval as first-line treatment."

Dr. Cho Byoung-Chul, a professor of medical oncology and head of Yonsei Cancer Center, recalled that when Leclaza was approved as a second-line treatment, it was also offered to patients through EAP.

"As a clinician, the EAP program is a blessing for patients. No company that has developed a more effective drug, or a treatment for which there are no existing options, come forward to participate in the EAP,” Professor Cho said. “There's no support for research, and one must go through many procedures to apply. But companies do so only for patients."

Regarding the first two patients prescribed Leclaza through EAP, a Yuhan official said, "What we announced earlier about the EAP program is now being implemented in the actual medical field. We will do our best to provide benefits to more patients."