At the Greater Los Angeles Oncology Nursing Society (GLAONS) Oncology Care Summit in Los Angeles, California, Teresa Knoop, MSN, RN, AOCN® gave a presentation on updates surrounding pharmacology. Oncology Data Advisor followed up with her, asking for advice on how to provide optimal pharmacological care for patients with cancer.
Oncology Data Advisor: How has the landscape of anticancer drugs evolved in the past year?
Teresa Knoop, MSN, RN, AOCN®: There are definite trends that we have seen in the landscape of anticancer drugs for the past few years, and those trends continue this year. The majority of new cancer treatment drugs approved by the FDA are molecularly targeted and immunotherapy agents. Those agents are not only being approved in metastatic settings but have also expanded to neoadjuvant, adjuvant, and maintenance settings. Formulations of these drugs are also changing. For instance, we are seeing subcutaneous formulations of monoclonal antibodies, which have traditionally been given intravenously. All of these advances continue to bring promise to our patients and give them options to spend less of their precious time in our clinics.
Another shift in the landscape is the approval of biosimilar agents for cancer treatment. A biosimilar is a biological product that is approved based on evidence that it is highly similar to an already approved biological product, known as a reference or an originator product. The biosimilar must show that it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Biosimilars offer our patients a more cost-effective option for treatment. Currently we have several biosimilars approved for use by the FDA, including seven for cancer supportive care and 10 for cancer treatment. We are sure to see many more approvals of biosimilars in the future.
In 2017, the FDA approved the first cellular gene therapy, calling it a historic action that would usher in a new approach to the treatment of cancer and other serious and life-threatening diseases. There have been five new cellular gene therapies approved for cancer treatment since 2017, with several of those agents already gaining expanded indications. More are in development through ongoing clinical trials.
A true paradigm shift in cancer treatment is the use of tumor agnostic drugs. These are drugs designed to treat genomic alterations, and they are not tumor histology–specific. This is a definite shift in how we have traditionally treated cancer. For example, if a patient has a certain alteration called a neurotrophic tyrosine receptor kinase (NTRK) fusion, there are now drugs to treat those alterations, regardless of the tumor-specific histology.
Oncology Data Advisor: What are your thoughts on the FDA withdrawals of certain drugs and indications?
Ms. Knoop: The FDA instituted programs like its Accelerated Approval, Fast Track, Breakthrough Therapy, and Priority Review programs to allow for earlier approval of drugs that treat serious conditions like cancer. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, the FDA has regulatory procedures in place that could lead to removing the drug from the market. Actually, per the FDA website, 5% or less of cancer drugs have been withdrawn between 1992 and 2020. I think that this should actually reassure those of us in cancer care that while we do want these drugs approved as quickly as possible, there is a mechanism to make sure the data is confirmed.
Oncology Data Advisor: How does the naming of generic medications help community oncologists in treating patients?
Ms. Knoop: Learning the generic or non-proprietary names of cancer drugs can certainly assist all of us who work in oncology in classifying and learning about the new drugs as they are approved. Those names give us the infrastructure to determine the class of agent and the likely side effects, as well as whether they are given orally, subcutaneously, or intravenously. I liken it to how we learned years ago about traditional chemotherapy classifications like alkylating agents and their expected side effects.
Oncology Data Advisor: How can education regarding the developing drug landscape help community oncologists in treating their patients?
Ms. Knoop: We all must keep up with the evolving landscape of cancer treatment, which can seem overwhelming at times, so any avenue we can use to keep abreast of these developments becomes crucial to providing optimal cancer care. We must be able to explain the mechanisms of action in lay terms, as well as determine how to assist our patients in managing side effects of these treatments so that the patients can stay on these drugs as long as they are effectively treating their cancer and so that the benefits outweigh the risks.
About Ms. Knoop
Teresa Knoop, MSN, RN, AOCN®, is a Director at Large on the Oncology Nursing Society Board of Directors. She recently retired from her position as the Assistant Director of Clinical Operations for the Clinical Trials Office at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. Her research has been published in nursing journals, and she regularly speaks on the topics of molecularly targeted cancer therapies and cancer clinical trials.
For More Information
US Food & Drug Administration (2018). Fast track, breakthrough therapy, accelerated approval, priority review. Available at: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
This transcript has been edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.