FDA approves Opdivo plus chemotherapy for unresectable or metastatic urothelial carcinoma
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The FDA approved nivolumab in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma, according to a press release.
Nivolumab (Opdivo, Bristol -Myers Squibb) is a PD-1 inhibitor previously approved for use in several malignancies, including two prior indications for urothelial carcinoma. The application for this indication received priority review by the FDA.
The agency based the approval on results of the randomized CHECKMATE-901 trial that assessed nivolumab plus chemotherapy in patients with previously untreated unresectable or metastatic urothelial carcinoma.
Researchers randomly assigned 608 adults in a 1:1 ratio to receive either nivolumab in combination with cisplatin and gemcitabine for up to six cycles followed by nivolumab alone for up to 2 years, or cisplatin and gemcitabine for up to six cycles.
Patients in both treatment arms who discontinued cisplatin received carboplatin in its place.
OS and PFS assessed by blinded independent central review served as the study’s major efficacy outcome measurements.
Results showed a median OS of 21.7 months (95% CI, 18.6-26.4) in the nivolumab arm vs. 18.9 months (95% CI, 14.7-22.4) in the control arm (HR = 0.78; 95% CI, 0.63-0.96).
Study investigators reported a median PFS of 7.9 months (95% CI, 7.6-9.5) in the nivolumab arm vs. 7.6 months (95% CI, 6-7.8) in the control arm (HR = 0.72; 95% CI, 0.59-0.88).
The most common adverse reactions that occurred in at least 15% of patients who received nivolumab included nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, peripheral neuropathy, urinary tract infection, diarrhea, edema, hypothyroidism and pruritus.
The recommended nivolumab dose is 360 mg every 3 weeks in combination with cisplatin and gemcitabine every 3 weeks for up to 6 cycles, followed by 240 mg every 2 weeks (or 480 mg every 4 weeks) as a single agent until disease progression, unacceptable toxicity or for a maximum treatment time of 2 years from first dose.
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