Biosimilars and Gene Therapy Are Making Great Strides in Cancer Care

Genitourinary Cancers

Combination ipilimumab plus nivolumab (https://voice.ons.org/news-and-views/fda-approves-nivolumab-plus-ipilimumab-combination-for-renal-cell-carcinoma) for intermediate- or poor-risk, previously untreated advanced renal cell carcinoma

• As with single-agent immune checkpoint inhibition, common adverse events include fatigue, rash, diarrhea, and musculoskeletal pain.
• Recommended dosing is nivolumab 3 mg/kg, followed by ipilimumab 1 mg/kg on the same day every three weeks for four doses, then nivolumab 240 mg every two weeks or 480 mg every four weeks.

Gynecologic Cancers

Rucaparib (https://voice.ons.org/news-and-views/fda-approves-rucaparib-for-treatment-of-recurrent-ovarian-cancer) for recurrent ovarian cancer

• Common adverse events include nausea, fatigue, abdominal pain/distension, rash, dysgeusia, anemia, and liver function test elevation.
• Recommended dosing is 600 mg orally twice a day.

Bevacizumab (https://voice.ons.org/news-and-views/fda-approves-bevacizumab-in-combination-with-chemotherapy-for-ovarian-cancer) in combination with chemotherapy for ovarian cancer

• Indicated for stage III and IV disease after initial surgical resection.
• Adverse events include diarrhea, nausea, stomatitis, fatigue, arthralgia, and muscular weakness.
• Recommended dosing is 15 mg/kg every three weeks with carboplatin and paclitaxel for up to six cycles, followed by 15 mg/kg every three weeks as a single agent, for a total of up to 22 cycles.

Hematologic Malignancies

Blinatumomab (https://voice.ons.org/news-and-views/fda-grants-accelerated-approval-to-blinatumomab-for-b-cell-precursor-all) for B-cell precursor acute lymphoblastic leukemia (ALL)

• Most common adverse events include pyrexia, infusion related reactions, headache and infections. Neurologic affects may prompt discontinuation of treatment.
• Recommended dosing is 15 mcg/m² per day via IV.

Tisagenlecleucel (https://voice.ons.org/news-and-views/fda-approves-tisagenlecleucel-for-adults-with-relapsed-or-refractory-large-b-cell) for adults with relapsed or refractory large B-cell lymphoma

• Previously approved for ALL, this form of CD-19 chimeric antigen receptor (CAR) T-cell therapy is now approved for some forms of lymphoma.
• Patients must be previously treated with two prior lines of therapy, including an anthracycline and rituximab for relapse following an autologous stem cell transplant. 
• As seen in other patient populations undergoing CAR T-cell therapy, common adverse events include cytokine release syndrome, neurologic effects, infections, and pyrexia.

Ventoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma with or without 17p deletion

• Patients eligible must have received at least one prior therapy. 
• Clinical trials involved administering ventoclax in combination with rituximab therapy.
• Tumor lysis syndrome is a prevalent risk, as is neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea.
• All approved dosing schedules begin with a five-week ramp up. Prescribing materials should be referred to for accurate dosing and schedules based on the indication for treatment.

Pembrolizumab (https://voice.ons.org/news-and-views/fda-approves-pembrolizumab-for-treatment-of-relapsed-or-refractory-pmbcl) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma

• Most common adverse events include musculoskeletal pain, upper respiratory tract infection, pyrexia, fatigue, cough, dyspnea, and diarrhea. 25% of patients required systemic corticosteroid therapy to manage side effects. 
• Recommended dosing for adults is 200 mg every three weeks, and for pediatric patients is 2 mg/kg every three weeks. 
• The drug is not recommended for treating patients requiring urgent cytoreductive therapy.

Melanoma

Dabrafenib (https://voice.ons.org/news-and-views/fda-approves-dabrafenib-plus-trametinib-for-adjuvant-treatment-of-melanoma-with-braf) plus trametinib for adjuvant treatment of BRAF V600E or V600K mutation positive melanoma

• In the setting of melanoma with these mutations and pathologic involvement of regional lymph nodes, significant relapse-free survival was noted.
• Common adverse events include pyrexia, nausea, headache, rash, chills, diarrhea, and vomiting. Dose reduction or interruption may be warranted. 
• Recommended dosing is dabrafenib 150 mg orally twice a day and trametinib 2 mg orally once a day.

Supportive Care

Epoetin alfa-epbx (https://voice.ons.org/news-and-views/fda-approves-epoetin-alfa-epbx-as-a-biosimilar-to-epoetin-alfa) as a biosimilar to epoetin alfa

• Approved for the treatment of anemia from chronic kidney disease, HIV infection, or the effects of myelosuppressive chemotherapy.
• The side-effect profile remains the same as epoetin alfa and includes myocardial infarction, stoke, venous thromboembolism, and thrombosis of vascular access.
• Dosing recommendations should mirror those of epoetin alfa.

Pegfilgrastim-jmdb (https://voice.ons.org/news-and-views/fda-approves-first-biosimilar-to-pegfilgrastim-to-decrease-cancer-treatment) as biosimilar to pegfilgrastim

• Approved for supportive care to reduce the risk of infection in patients undergoing myelosuppressive chemotherapy.
• Adverse events are similar to those with pegfilgrastim and include bone main and pain in extremities. Serious side effects are rupture of the spleen, acute respiratory distress, and allergic reactions. 
• Dosing recommendations should mirror those of pegfilgrastim.

As noted in each of the FDA approval alerts, continued reporting of observed adverse events will enable healthcare providers to have a better sense of the acute and long-term effects and fully understand patients’ survivorship needs. Through ONS’s Recognize It; Report It campaign, nurses are encouraged to report adverse events to providers for appropriate management, as well as the FDA for widespread dissemination of what patients on these agents are experiencing. Continue to follow ONS for the most up to date approval notifications.