FDA Drug Innovation - Anktiva

New Drug Approval 

In a significant development for patients battling BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the Food and Drug Administration (FDA) has granted approval to nogapendekin alfa inbakicept-pmln, marketed as Anktiva by Altor BioScience, LLC. This approval, announced on April 22, 2024, marks a crucial step forward in addressing this challenging form of bladder cancer. 

Efficacy and Safety 

The approval was based on findings from the QUILT-3.032 trial, a multicenter study involving 77 patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. Patients received Anktiva induction therapy via intravesical instillation alongside BCG, followed by maintenance therapy for up to 37 months. The trial demonstrated a compelling complete response (CR) rate of 62%, with a significant proportion of patients experiencing durable responses lasting 12 months or more. 

Dosage and Administration 

Anktiva is recommended to be administered intravesically with BCG once a week for six weeks as induction therapy. Patients who do not achieve CR at month three may receive a second induction course. Following induction, maintenance therapy consists of intravesical administration once a week for three weeks at specific intervals. Treatment duration should not exceed 37 months. 

Adverse Reactions 

Common adverse reactions associated with Anktiva include increased creatinine, dysuria, hematuria, urinary frequency, and urinary tract infections. Healthcare providers are advised to monitor patients closely for any signs of adverse events during treatment. 

Expedited Programs 

The FDA utilized expedited review programs, including the Assessment Aid and breakthrough designation, to facilitate the evaluation of Anktiva for this serious condition. These programs expedite the development and review of drugs intended to treat severe or life-threatening conditions. 

Reporting Adverse Events 

Healthcare professionals are encouraged to report any serious adverse events associated with Anktiva or other medications to the FDA’s MedWatch Reporting System. This ensures ongoing monitoring and evaluation of the drug’s safety profile. 

Conclusion 

The approval of Anktiva represents a significant advancement in the treatment landscape for BCG-unresponsive NMIBC, offering new hope to patients and healthcare providers alike. Information on Anktiva, including full prescribing information, will be posted on the FDA’s website. 

Links

Read the FDA New Drug Announcement here.