USA —The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ first gene therapy for treating adult patients with bladder cancer.

The therapy, Adstiladrin, is for patients with an aggressive form of the disease whose only other option is to have their bladder removed.

In a clinical study, the gene therapy was 51 percent effective in total disappearance of all cancer signs.

The treatment, which is administered into the patient’s bladder once every three months, causes the body to produce a protein that fights cancer.

Bladder cancer is one of the most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing about 75% of all such cases.

The bladder cancer drugs market is expected to reach US$4.1 billion by 2026, growing at a 14.9% CAGR. Retrospectively, the global bladder cancer drugs market grew from US$1.97 billion in 2021 to US$2.35 billion in 2022 at a compound annual growth rate (CAGR) of 19.2% according to Business Research Company.

This increased incidence of bladder cancer increases demand for bladder cancer drugs, which contributes to market growth.

The number of bladder cancer cases is increasing. The rise is abetted by unsanitary workplace exposures, an increase in smoking habits, and drinking arsenic-laced water all increase the risk of bladder cancer.

According to the American Cancer Society, there were 81,400 new cases of bladder cancer in 2020, with men accounting for 62,100 of the cases and women accounting for 19,300.

Because of a severe BCG shortage, guidelines now recommend using adjuvant BCG only for high-risk NMIBC patients.

The adenovirus vector-based gene therapy is indicated for adults with high-risk non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.

Bladder cancer is the most expensive cancer to treat and has a high recurrence rate. The cost of gene therapy has not yet been announced, but a cost-effectiveness analysis from the Institute for Clinical and Economic Review, published last year, put the range for the annual cost between US$158,600 and US$262,000.

Patients with high-risk NMIBC are commonly treated with a direct instillation of the immunotherapeutic BCG (Bacillus Calmette-Guérin).

Ferring expects the gene therapy to be commercially available in the United States in the second half of 2023.

In April 2019, Bristol-Myers Squibb Company, an American pharmaceutical company got the approval to acquire Celgene corporation for US$74 billion.

The transaction helps Bristol-Myers acquire a bigger market share of immuno-oncology drugs including bladder cancer drugs in the USA and compete with its competitors in the biologics and targeted therapies space.

Celgene Corporation, a company that develops medicines for cancer and inflammatory disorders, was founded in 1996 and has its headquarters in the USA.

Major players in the bladder cancer drugs market are Pfizer, Celgene Corporation, Eli Lilly, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi, Roche, Novartis, and Johnson & Johnson.

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