Balversa, the first targeted anticancer drug for bladder can

Changes in bladder cancer treatment due to the emergence of targeted anticancer drugs following immuno-cancer drugs

The Ministry of Food and Drug Safety approves Balversa, a targeted treatment for FGFR

FGFR mutation found in 20~30% bladder cancer, 32% OR

Balversa

Targeted options targeting specific genetic mutations in bladder cancer have emerged for the first time.

 

The Ministry of Food and Drug Safety announced on the 24th that it had approved Janssen's Balversa.

 

It is an indication of metastatic urinary epithelial cancer (cystic cancer) with at least one type of chemotherapy treatment, or FGFR2 or 3 mutations within 12 months of adjuvant treatment before and after surgery, including platinum-based chemotherapy.

 

Bladder cancer is representative cancer that had no targeted anticancer drugs.

 

Balversa has become the first targeted anticancer drug for bladder cancer with a new mechanism called FGFR inhibition.

 

FGFR is one of the bio-signals involved in cancer cell growth and is associated with several carcinomas.

 

In particular, FGFR mutations are commonly observed in bladder cancer, and about 20 to 30% of patients are known to have mutations.

 

The phase 2 BLC2001 study, which served as the basis for Balversa approval, targeted 99 patients with local progressive and metastatic urinary tract epithelial cancer with FGFR mutations.

 

The ORR of 87 people who can be evaluated was 32.2% based on the IRRC evaluation.

 

The disease control rate was 78% and the median response duration was 5.4 months.

 

The progression-free survival (PFS) median and OS median were 5.5 months and 13.8 months, respectively.

 

The most commonly reported adverse reactions of Grade 3 or higher include canker soreness, hand toenail dystrophy, hand toenail disorder, corneal inflammation, and hyperphosphatemia.

 

Significant adverse reactions occurred in 41% of patients, of which eye disorders were reported by 10%.

 

The adverse reactions that resulted in fatal results occurred in 1% of patients due to acute myocardial infarction.

 

Based on the second phase, the Balversa permit was approved in April 2019, three years earlier than Korea in the U.S.

 

To diagnose FGFR3 mutations, QuantiFERON's Therascreen FGFR Kit was also approved as a companion diagnostic device.

 

◆ A treatment for bladder cancer that has not existed for decades Bladder cancer is cancer that has been stagnant for decades.

 

Unlike other cancers where several targeted anticancer drugs appeared, bladder cancer has been the main treatment until recently.

 

The development of new drugs was not easy because of the high effectiveness of early chemotherapy.

 

However, in metastatic bladder cancer, chemotherapy reacts in the early stages, and most of them die within two years due to resistance.

 

The birth of the first targeted anticancer drug for bladder cancer

Recently, immuno-cancer drugs have emerged, causing changes in the treatment of bladder cancer.

 

There are four immuno-cancer drugs, including Keytruda, Opdivo, Tecentriq, and Bavencio, and there is a slight difference in specific indications.

 

Keytruda and Tecentriq can be used as primary treatments.

 

However, it can be used only when PD-L1 expression is positive and Cisplatin-based chemotherapy is impossible.

 

Bavencio can be used as a maintenance therapy without the disease progressing after using chemotherapy in the first round.

 

Opdivo is used as a secondary treatment when the disease progresses after chemotherapy.

 

Keytruda and Tecentriq can also be used in the second round.

 

Immuno-cancer drugs have a high response rate of around 20%, but they have fewer side effects than chemotherapy and have the advantage of maintaining treatment responses for a long time.

 

With Balversa's permission, patients with FGFR mutations can consider targeted anticancer drugs in secondary or higher treatment, which is expected to help improve their prognosis.