Nivolumab (Opdivo; Bristol Myers Squibb) is FDA accredited for 11 most cancers indications, with the latest approval to be used together with sure chemotherapy for the preliminary therapy of gastric most cancers.
Nivolumab (Opdivo; Bristol Myers Squibb) is an immunotherapy that’s FDA accredited for 11 most cancers indications,1 with the latest approval to be used together with sure chemotherapy for the preliminary therapy of gastric most cancers.2 This newest motion marks an necessary milestone as the primary FDA-approved immunotherapy for first-line therapy of gastric most cancers.2
Pharmacists can play an necessary function in managing sufferers receiving nivolumab remedy.
Nivolumab was accredited April 16, 2021 and beforehand acquired precedence evaluate, and breakthrough remedy, and orphan drug designations to be used together with fluoropyrimidine and platinum-containing chemotherapy for the therapy of sufferers with superior or metastatic gastric most cancers, gastroesophageal junction most cancers, and esophageal adenocarcinoma.2 Approval was primarily based on the section 3 CheckMate-649 trial (NCT02872116) that demonstrated nivolumab plus chemotherapy had superior general survival in contrast with chemotherapy alone (P = 0.0002).3 Moreover, 55% of sufferers within the nivolumab plus chemotherapy group have been alive at 1 12 months in contrast with 48% sufferers within the chemotherapy alone group.3
Further cancers handled by nivolumab consists of the next:1
- Non-Small Cell Lung Most cancers (NSCLC)
- Malignant Pleural Mesothelioma
- Renal Cell Carcinoma (RCC)
- Classical Hodgkin Lymphoma (cHL)
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Urothelial Carcinoma
- Colorectal Most cancers
- Hepatocellular Carcinoma (HCC)
- Esophageal Most cancers
Mechanism of Motion
Opdivo is a monoclonal antibody that works by binding to the PD-1 receptor and inhibits tumor development by enhancing T-cell perform.1,2
Dosage and Administration
Nivolumab is run by intravenous (IV) infusion over half-hour, and the dosage is dependent upon the indication (see Desk 1) and whether or not it’s given as mixture therapy or monotherapy.1 Nivolumab may be administered together with ipilimumab (Yervoy; Bristol Myers Squibb), cabozantinib (Cabometyx; Exelixis), fluoropyrimidine and platinum-containing chemotherapy.1 Nivolumab needs to be administered first adopted by these therapies on the identical day when getting used as mixture therapy: ipilimumab; platinum-doublet chemotherapy; ipilimumab and platinum-doublet chemotherapy (administer nivolumab, adopted by ipilimumab, then platinum-doublet chemotherapy); and fluoropyrimidine and platinum-containing chemotherapy.
Warnings, Precautions, and Affected person Counseling Factors
Nivolumab could cause extreme or life-threatening immune-mediated opposed reactions, so it’s vital for pharmacists to watch and educate sufferers in regards to the potential indicators and signs to look at for, and advocate searching for medical consideration instantly in the event that they expertise them to find out whether or not remedy needs to be withheld or discontinued (see Desk 2).1 It is very important particularly monitor sufferers’ liver enzymes, creatinine, and thyroid perform at baseline and periodically throughout therapy.1 People who acquired allogeneic hematopoietic stem cell transplantation can expertise extreme or deadly problems in the event that they underwent transplantation earlier than or after nivolumab remedy, so it’s important to carefully monitor sufferers.1
Sufferers experiencing extreme infusion-related reactions ought to have nivolumab withheld. Nivolumab needs to be completely discontinued for life-threatening immune-mediated opposed reactions, recurrent extreme immune-related reactions that require systemic therapy, or the shortcoming to scale back the corticosteroid dose to 10 mg or much less of prednisone or equal per day inside 12 weeks of beginning steroid remedy. The infusion may be interrupted or the speed slowed in sufferers with delicate or average infusion-related reactions.1
Being pregnant and Lactation
Based mostly on knowledge from animal research, nivolumab could cause fetal hurt when administered to pregnant ladies. Girls of kid bearing potential ought to obtain a being pregnant take a look at earlier than beginning nivolumab therapy. Sufferers needs to be endorsed to make use of an efficient contraception throughout therapy and for at the very least 5 months after the final dose of Opdivo. It’s unknown whether or not nivolumab passes into the breast milk so sufferers needs to be suggested to keep away from breastfeeding throughout therapy and for five months after the final dose.1
- Opdivo. Prescribing data. Bristol Myers Squibb; 2021. Accessed July 10, 2021.https://packageinserts.bms.com/pi/pi_opdivo.pdf
- FDA approves first immunotherapy for preliminary therapy of gastric most cancers [News release].FDA. April 16, 2021. Accessed July 10, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-initial-treatment-gastric-cancer.
- U.S. Meals and Drug Administration approves Opdivo (nivolumab) together with chemotherapy for sufferers with superior or metastatic gastric most cancers, gastroesophageal junction most cancers, and esophageal adenocarcinoma, no matter PD-L1 expression standing [News release]. April 16, 2021, Bristol Myers Squibb. Accessed July 10, 2021.https://news.bms.com/news/corporate-financial/2021/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-in-Combination-with-Chemotherapy-for-Patients-with-Advanced-or-Metastatic-Gastric-Cancer-Gastroesophageal-Junction-Cancer-and-Esophageal-Adenocarcinoma/default.aspx.