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In a year marked by collaboration and innovation, therapeutic developments in oncology care once again dominated the novel drug approvals in 2020.
In a year marked by collaboration and innovation, therapeutic developments in oncology care once again dominated the novel drug approvals in 2020. In total, 21 novel agents were approved across hematology/ oncology, including 3 diagnostic imaging agents for the treatment of patients with breast cancer, prostate cancer, and neuroendocrine tumors, respectively. Additionally, new formulations and expanded indications and biosimilar approvals across tumor types opened up the accessibility of agents for patient populations, including reduced time in the clinic.
Such approvals included subcutaneous daratumumab (Darzalex) plus hyaluronidase-fihj (Darzalex Faspro), which reduces the administration time from hours for intravenous daratumumab to minutes for patients with multiple myeloma. Additionally, the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) was approved, providing an outpatient treatment option patients with HER2-positive breast cancer. Further, the approval of the novel oral formulation of decitabine and cedazuridine (Inqovi), marked the first nonintravenous treatment for patients with myelodysplastic syndromes (MDS).1,2
The year 2020 was a decidedly promising one for patients with lung cancer, in particular those with nonsmall cell lung cancer (NSCLC). Specifically, the FDA approved 3 novel agents for patients with NSCLC and expanded the indication of 6 other agents. Two agents, selpercatinib (Retevmo) and pralsetinib (Gavreto), were approved for patients harboring RET mutations and for patients with indications that include medullary thyroid cancer (MTC).1
Approvals in other rare cancers also shared the spotlight in 2020, including those for gastrointestinal stromal tumors (GIST), a malignancy that affects the walls of the digestive system. The first, avapritinib (Ayvakit), joined 3 other targeted agents for the treatment of patients with this disease. The second, ripretinib (Qinlock), became the first agent approved in the fourth line for those patients who have exhausted all approved treatment options.1,2
The 21 novel agents approved across hematology/ oncology, in chronological order, are the following:
The FDA granted approval for the following indications:
Brexucabtagene autoleucel (Tecartus), a CD19-directed genetically modified autologous T-cell immunotherapy, was approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
1. Novel drug approvals for 2020. FDA. Updated January 13, 2021. Accessed January 17, 2021. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020
2. Hematology/oncology (cancer) approvals & safety notifications. FDA. Updated January 15, 2021. Accessed January 17, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
3. Biosimilar product information. FDA. Updated December 17, 2020. Accessed January 17, 2021. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information