The FDA recently approved the first gene therapy for bladder cancer, Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg). Almost three-quarters of oncologists surveyed by Zitter Insights expressed at least moderate interest in the agent, and payers said they likely will manage the drug to label.
On Dec. 16, the FDA approved Adstiladrin for the treatment of adults with high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The agency gave the novel adenovirus vector-based gene therapy priority review, breakthrough therapy and fast track designations. Dosing is once every three months into the bladder via a urinary catheter. The company said it expects the therapy to be available in the second half of 2023.
The FDA decision comes after the agency issued a complete response letter in May 2020 for the product — which previously was known as Instiladrin — declining to approve it due to manufacturing issues.
Adstiladrin likely will compete with Merck & Co., Inc.’s Keytruda (pembrolizumab), which was approved Jan. 8, 2020, for BCG-unresponsive, high-risk NMIBC with CIS with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Multiple other agents are in late-stage clinical trials for high-risk NMIBC, many of them in the BCG-unresponsive setting.
“Patients with BCG-unresponsive NMIBC have historically had limited treatment options other than bladder removal surgery,” Steven A. Boorjian, M.D., Carl Rosen Professor and chair of the department of urology at Mayo Clinic, and lead investigator on the recent clinical trial of Adstiladrin, said in a statement. “The approval of Adstiladrin is therefore a significant advance in the current treatment landscape and provides a novel treatment option for patients.”
For the Managed Care Oncology Index: Q1 2022, from March 3, 2022, to April 7, 2022, Zitter Insights polled 36 commercial payers covering 117.3 million lives and 101 oncologists about their management and treatment of bladder cancer. Payers covering almost half of commercial lives expressed some awareness of Adstiladrin, while more than half of oncologists said the same. However, 72% of the oncologist respondents said they were at least moderately interested in the gene therapy (see chart).
Both AIS Health and Zitter Insights are divisions of MMIT.
Commercial payers with 79% of beneficiaries said that they expected to manage Adstiladrin to label within six months of its launch. One respondent noted the agent’s “potential to be better than standard of care” and the patient population’s “high unmet need.” Payers also said that they likely would put step therapy requirements in place for the product, while one respondent said their health plan may put quantity limits on it.
For more information on the Zitter Insights data, contact Jill Kettler at firstname.lastname@example.org.