Giotrif competitor Vizimpro close to receiving reimbursement

Passed Cancer Deliberation Committee, awaits DREC deliberation in October

The medication accepts weighted average pricing of alternative treatment to be exempted out of negotiation

Sources report, Pfizer Korea is speeding up the procedure to introduce epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) into the market.

 

According to the industry sources, a fifth EPGF TKI Vizimpro (dacomitini) has passed the Health Insurance Assessment and Review Service (HIRA) Cancer Deliberation Committee in last July, and it is waiting for Drug Reimbursement Evaluation Committee’s (DREC) deliberation in October.

 

Although the DREC deliberation was initially scheduled be convened in September, the deliberation was delayed due to the resurging number of confirmed COVID019 cases.

 

Currently, the first generation EGFR TKI ‘Iressa (gefitinib)’ by AstraZeneca and Tarceva (erlotinib) by Roche, and the second generation Giotrif and the third generation Tagrisso (osimertinib) by AstraZeneca are prescribed in South Korea.

 

As its direct competitor Giotrif (afatinib) has already settled in the market already, Vizimpro chose the drug pricing negotiation exemption track.

 

As a result, its launch would be able to convince the product from then on in the second half of the year.

 

Vizimpro’s efficacy has been confirmed in Phase III ARCHER 1050 trial.

 

The study compared Vizimpro and the first-generation Iressa head-to-head with total 452 patients fighting against non-small cell lung cancer (NSCLC).

 

In the trial, the medicine reduced the risk of progression-free survival (PFS) by 41 percent than Iressa, when Vizimpro patient group’s median PFS was at 14.7 months and Iressa group’s was at 9.2 months.

 

The study reported Vizimpro lowered the risk of progression or death by 41 percent against Iressa, and the median progression-free survival (PFS) was 14.7 months in the Vizimpro group and 9.2 months in the Iressa group.

 

Nevertheless, Vizimpro showed worse cases of adverse reactions.

 

In the Vizimpro group, the frequently demonstrated severe adverse reactions included dermatological issues with pimple (14 percent) and diarrhea (8 percent), whereas changes in liver enzymes (8 percent) were significant in the Iressa group.

 

Around 60 percent of Vizimpro patient group had to adjust their medication dose due to adverse reaction.

 

Vizimpro is a second-generation targeted therapy indicated to treat patients with EGRF-mutation-positive NSCLC.

 

The U.S.

 

Food and Drug Administration (FDA) approved the anticancer treatment in September 2018 after granting Priority Review in January same year.

 

Currently, the drug is approved and used in the U.S., EU and Japan.

 

In Korea, the medication has been approved as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, and it is also indicated treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, who has not been treated before.