Biosimilars and Gene Therapy Are Making Great Strides in Cancer Care

September 25, 2018 by Kathleen Wiley MSN, RN, AOCNS®

As researchers learn more about how combination therapy combats drug resistance and lessens the changes of tumor evasion of the immune system, immune checkpoint inhibitors are receiving approval for a broader range of indications. However, recent U.S. Food and Drug Administration (FDA) approvals have centered around hematologic malignancies and the emergence of two new biosimilars.

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

Gynecologic Cancers

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

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

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)

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

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

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

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

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

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


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