The Top 10 FDA Oncology Drug Approvals of 2020


Here are the top 10 FDA oncology drug approvals that you may have missed this year.

While 2020 had its share of negative healthcare headlines, the Food and Drug Administration (FDA) continued to push through approvals on a large number of oncology therapies throughout the year, from acute myeloid leukemia (AML) to breast cancer and beyond.

Here’s a look back at 2020’s top 10 most popular FDA drug approvals in the oncology space, as determined by CURE readers.

10.FDA Approves Kyprolis in Combination with Darzalex and Dexamethasone for Relapsed/Refractory Multiple Myeloma

In August, the FDA approved the expansion of Kyprolis (carfilzomib) in combination to with Darzalex (daratumumab) plus dexamethasone in once- and twice-weekly dosing regimens for the treatment of patients with relapsed or refractory multiple myeloma who have received a maximum of three prior lines of therapy.

9. FDA Grants Regular Approval to Venclexta Combo for Untreated Acute Myeloid Leukemia

After granting it an accelerated approval in 2018, the Food and Drug Administration fully approved Venclexta (venetoclax) in combination with Vidaza (azacytidine), Dacogen (decitabine) or low dose cytarabine (LDAC) in newly diagnosed patients with AML aged 75 years or older in October.

8. Monjuvi-Revlimid Combination Approval Fills Unmet Need for Certain Patients with DLBCL

The combination of Monjuvi (tafasitamab-cxix) and Revlimid (lenalidomide), approved in August, fills an unmet need for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are also unable to undergo autologous stem cell transplant, said Dr. Gilles Salles.

7. FDA Approves Qinlock for Patients with Pretreated, Advanced GIST

The targeted drug Qinlock (ripretinib), which interferes with the activity of proteins that drive gastrointestinal stromal tumor (GIST), was approved by the FDA in May for patients with advanced disease that has progressed despite treatment with other kinase inhibitors.

6. FDA's Approval of Braftovi-Erbitux Combination Presents 'A Small Step Forward' for Patients with Metastatic Colorectal Cancer

The FDA’s approval of Braftovi (encorafenib) and Erbitux (cetuximab) with or without Mektovi (binimetinib) for adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation is a welcomed approval, according to Dr. Richard Goldberg, because patients with this mutation have a poorer than average prognosis and more limited treatment options than other colorectal cancer patients. “Having an effective, rationally designed regimen for them that attacks multiple points in the pathway that drives their tumor was sorely needed,” said Goldberg.

5. FDA Approves Retevmo for Three Cancer Types with RET Alterations

In May, the FDA approved Retevmo (selpercatinib), the first of its kind, to treat non-small cell lung cancer (NSCLC), medullary thyroid cancer and other types of thyroid cancers with rearranged during transfection, or RET, alterations. The kinase inhibitor blocks a type of enzyme and helps prevent cancer cells from growing.

4. FDA Approves Gavreto for Metastatic Non-Small Cell Lung Cancer Subset

The FDA approved and granted priority review in September to Gavreto (pralsetinib) for the treatment of patients with metastatic, RET fusion-positive NSCLC. “The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease,” said Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development, in a statement.

3. FDA's Trodelvy Approval a 'Big Win' for Patients with Metastatic Triple-Negative Breast Cancer

The Food and Drug Administration’s May approval of the first antibody-drug conjugate to treat patients with pretreated metastatic triple-negative breast cancer was a major milestone, according to Dr. Aditya Bardia, a breast medical oncologist at Massachusetts General Hospital Cancer Center.

2. FDA Approves Every Six-Week Dose of Keytruda Across All Indicated Cancer Types

This approval in April was big news for patients with a variety of adult cancers. “The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a press release. “Today’s approval of an every-six-weeks dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”

1. FDA Approves Nerlynx-Xeloda Combo For HER2-Positive Breast Cancer

Our most popular approval coverage for the combination of Nerlynx and Xeloda in February comes off the heels of the phase 3 NALA trial that looked at the efficacy of Nerlynx in combination with Xeloda, which found a significant improvement in patient’s progression free survival (the time from treatment to disease progression or worsening) compared to Tykerb (lapatinib) in combination with Xeloda.

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