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Published on: February 7, 2021
Novel and Expanded Oncology Drug Approvals of 2016-PART 1: New Options in Solid Tumor Management
Abstract:
The nonradiologic medical management of solid tumors has evolved from the use of traditional cytotoxic agents to modern targeted therapies, monoclonal antibodies, and immunotherapies. Advances in the understanding of cancer biology and therapeutic strategies have resulted in increasing numbers of new drug applications and approvals. Consequently, practicing oncologists need to learn how the newly available agents function and what toxicities to watch for, as well as ways to optimize the use of both new drugs and previously approved drugs with new indications. In 2016, the US Food and Drug Administration approved three novel drugs for the treatment of solid malignancies-olaratumab in selected patients with soft-tissue sarcoma, atezolizumab for the treatment of bladder cancer, and rucaparib for the treatment of ovarian cancer; also in 2016, the use of previously approved anticancer agents (including atezolizumab) was expanded into 11 new patient populations. The diversity of options for patients is evident in the broad range of the 2016 approvals, which include immune checkpoint inhibitors, targeted therapies, monoclonal antibodies, and traditional cytotoxic agents. This article focuses on the new agents and indications that emerged in 2016 for solid tumor treatment. We review the drug indications, mechanisms of action, pivotal trial data, pertinent toxicities, use in special populations, and the appropriate clinical contexts for treatment planning.
Insights
In 2016, the US Food and Drug Administration approved novel drugs and expanded indications for cancer therapies, including targeted therapies and immunotherapies for solid tumors. Oncologists must understand these new agents, their toxicities, and optimal usage for improved patient outcomes.
Area of Science:
- Oncology
- Pharmacology
- Cancer Biology
Background:
- Nonradiologic medical management of solid tumors has evolved significantly.
- Advances in cancer biology have led to new targeted therapies, monoclonal antibodies, and immunotherapies.
- Practicing oncologists require updated knowledge on new drug mechanisms, toxicities, and optimal use.
Purpose of the Study:
- To review novel drugs and expanded indications for solid tumor treatment approved in 2016.
- To provide oncologists with essential information for clinical decision-making.
- To discuss drug indications, mechanisms of action, trial data, toxicities, and special populations.
Main Methods:
- Review of US Food and Drug Administration (FDA) approvals in 2016 for solid malignancies.
- Analysis of pivotal trial data for newly approved and expanded-use anticancer agents.
- Synthesis of information on drug indications, mechanisms, toxicities, and clinical contexts.
Main Results:
- In 2016, three novel drugs (olaratumab, atezolizumab, rucaparib) were approved for specific solid tumors.
- The use of previously approved agents, including atezolizumab, was expanded to 11 new patient populations.
- Approvals encompassed diverse therapeutic classes: immune checkpoint inhibitors, targeted therapies, monoclonal antibodies, and cytotoxic agents.
Conclusions:
- The landscape of solid tumor treatment expanded considerably in 2016 with new drug approvals and indications.
- Understanding the nuances of these diverse therapeutic options is crucial for effective cancer care.
- This review equips oncologists with knowledge to optimize treatment planning for patients with solid tumors.
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