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.
Heres a look back at 2020s top 10 most popular FDA drug approvals in the oncology space, as determined by CURE readers.
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.
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.
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.
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.
The FDAs 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.
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.
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, Genentechs chief medical officer and head of Global Product Development, in a statement.
The Food and Drug Administrations 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.
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. Todays 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.
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 patients progression free survival (the time from treatment to disease progression or worsening) compared to Tykerb (lapatinib) in combination with Xeloda.
- Asia-Pacific Cell Therapy Market 2021-2028 - Opportunities in the Approval of Kymriah and Yescarta - PRNewswire - August 5th, 2021
- Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of ... - The Bakersfield Californian - August 5th, 2021
- IDH1 Inhibitors, CAR T-Cell Therapy, and Third-Generation TKIs Refresh Relapsed/Refractory Leukemia Landscape - OncLive - August 5th, 2021
- Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients -... - August 5th, 2021
- Is This Small-Cap Biotech a Buy After Its Second Approved Gene Therapy? - Motley Fool - August 5th, 2021
- Defining Cell Culture Lines and Media - The Scientist - August 5th, 2021
- Preimplantation Genetic Testing Demand to Grow by 9% CAGR Annually, through 2031 - BioSpace - August 5th, 2021
- Cell Therapy Global Market Report 2021: COVID-19 Growth and Change to 2030 - ResearchAndMarkets.com - Business Wire - July 7th, 2021
- A New Era For FDA Regulation Of Cell And Tissue Products - Law360 - July 7th, 2021
- UM School Of Medicine Researchers Receive NIH Avant Garde Award For Out-Of-Box, Innovative Concept To Cure HIV And Treat Co-Existing Addiction -... - July 7th, 2021
- Antengene Announces Acceptance of IND Application in China for the Phase II Clinical Trial of Single-Agent Selinexor for the Treatment of... - July 7th, 2021
- The Top Doctors in the Twin Cities, 2021 - Mpls.St.Paul Magazine - July 7th, 2021
- The stem cell market was valued at USD 14.7 billion in 2020, and it is expected - GlobeNewswire - June 8th, 2021
- Innovative Regenerative Medicine Therapies Safety Comes First - FDA.gov - June 8th, 2021
- Early Promise of AntiCLL-1 CAR T-Cell Therapy Reported in Pediatric AML - Cancer Network - June 8th, 2021
- Part 3: Moving Forward and Keeping Stem Cell Treatments Safe - MedShadow - June 8th, 2021
- In Some Heavily Pretreated Patients with R/R MM Ide-Cel Continues to Show Deep and Durable Responses - Targeted Oncology - June 8th, 2021
- Innovative research refines the treatment of patients with advanced cancers and the use of immunotherapy - Network News, Press Releases - Hackensack... - June 8th, 2021
- Mustang Bio to Host Key Opinion Leader Webinar on MB-106 CD20-Targeted CAR T for the Treatment of High-Risk B-Cell Non-Hodgkin Lymphomas and Chronic... - June 8th, 2021
- Karen Hasty Named Among 2021 Super Women In Business by Memphis Business Journal - UTHSC News - June 8th, 2021
- High Overall Response Rates Achieved With Cirmtuzumab/Ibrutinib in MCL and CLL - Targeted Oncology - June 8th, 2021
- New Data on KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Versus Sunitinib in First-Line Treatment for Patients With Advanced Renal Cell... - June 8th, 2021
- Chao family gifts to UCI Health for cancer care top $50 million - UCI News - June 8th, 2021
- Sorrento and Researchers at Karolinska Institutet Have Signed a Research Collaboration Agreement on iPSC-Derived Dimeric - GlobeNewswire - June 8th, 2021
- Responses to Tafasitamab/Lenalidomide in DLBCL Sustained at Three Years - Cancer Network - June 8th, 2021
- The regenerative medicine market size to grow at a CAGR of around 30% during the period - GlobeNewswire - June 8th, 2021
- 'Natural Killer Cells' and Other Promising Cancer Treatments - Barron's - April 18th, 2021
- Capturing the Pandemic Experience in Haiku Poetry - Duke Today - April 18th, 2021
- Chemotherapy for Prostate Cancer: When It's Used and What to Expect - Healthline - April 18th, 2021
- Signs that Chemo Is Working: How Effectiveness Is Measured and Defined - Healthline - April 18th, 2021
- Some experts fear next-generation Covid vaccines may be worse - STAT - April 18th, 2021
- How Long is Chemotherapy? What to Expect - Healthline - April 18th, 2021
- Regenerative Medicine - Stem Cell Therapy Little Rock - March 8th, 2021
- Center for Stem Cell Biology & Regenerative Medicine ... - March 8th, 2021
- Dynamic Stem Cell Therapy Offers Regenerative Medicine - Las Vegas Review-Journal - March 8th, 2021
- Anti-EGFR VHH-armed death receptor ligandengineered allogeneic stem cells have therapeutic efficacy in diverse brain metastatic breast cancers -... - March 8th, 2021
- Research Antibodies Market Size to Reach USD 5325.8 Million by 2027 | Increasing R&D Activities in the Fields of Oncology, Neurobiology, and Stem... - March 8th, 2021
- Microwave Processing Isolates Red Ginseng Compounds That Suppress Lung Cancer Metastasis - Genetic Engineering & Biotechnology News - March 8th, 2021
- Longeveron Expands Enrollment Criteria for its Phase 1 RECOVER Trial Evaluating Lomecel-B Infusion to Treat Acute Respiratory Distress Syndrome due to... - March 8th, 2021
- Be The Match BioTherapies Announces Expansion of Multi-Year Strategic Alliance with Orchard Therapeutics to Support European Commercial Launch of... - March 8th, 2021
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2021: Focuses at the key worldwide companies to Define, Describe and Analyses the sales... - March 8th, 2021
- Editing Reproduction: CRISPR and preventing heritable diseases, With Dr. Dietrich Egli and Dr. Sam Sternberg - Columbia University Irving Medical... - March 8th, 2021
- U. Cancer Center pilot projects: investigating cancer connections - The Brown Daily Herald - March 8th, 2021
- COVID-19 can kill heart muscle cells, interfere with contraction Washington University School of Medicine in St. Louis - Washington University School... - March 8th, 2021
- Vaccinating by age groups is unfair, particularly to minorities, advisory panel tells CDC - USA TODAY - March 8th, 2021
- Winter Weather Impacting Blood and Platelet Donations - Milwaukee Community Journal - February 17th, 2021
- Joshua Shirk continues to fight the odds; mom says God placed people where they needed to be to help him - Keyser Mineral Daily News Tribune - February 17th, 2021
- Evotec and Medical Center Hamburg-Eppendorf Enter Partnership to Develop iPSC-Based Tissue Therapy for Heart Failure - GuruFocus.com - February 7th, 2021
- ProgenCell - Stem Cell Therapies offers an updated Stem Cell Therapy for Anti Aging Protocol - PR Web - January 30th, 2021
- Doctors urge immunocompromised to get COVID vaccine when it becomes available - KMTV - 3 News Now - January 30th, 2021
- Autologous Stem Cell and Non Stem Based therapies Market Share, Size 2021 Global Industry Future Trends, Growth, Strategies,, Segmentation, In-depth... - January 30th, 2021
- Studies Indicating T-Cells May Be Needed For Long-Term Protection From The SARS-Cov-2 Virus - PRNewswire - January 30th, 2021
- Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health - January 30th, 2021
- Two Gene Therapies Fix Fault in Sickle Cell Disease and -thalassemia - MD Magazine - January 30th, 2021
- If I Have Cancer, Dementia or MS, Should I Get the Covid Vaccine? - Kaiser Health News - January 30th, 2021
- L-MIND Trial Results Show CD19 Antibody Is Reasonable in R/R DLBCL - Targeted Oncology - January 30th, 2021
- Profile of T Cells, Broadly Neutralizing Antibodies, Anti-Viral Targets: COVID-19 Updates - Bio-IT World - January 30th, 2021
- HealthLynked's The Future of Healthcare Summit Brings Healthcare Experts and Technology Innovators from Around the World to Naples, Florida - WFMZ... - January 30th, 2021
- Tevogen Bio Secures Funding from Team of Doctors to Support Clinical Trials of Its Investigational Curative T Cell Therapy for COVID-19 - PRNewswire - January 25th, 2021
- Novel Treatment Leads to Dog's Recovery - The Bark - January 25th, 2021
- Identification and Targeting of ThomsenFriedenreich and IL1RAP | OTT - Dove Medical Press - January 25th, 2021
- Regenerative Medicine Market Size Worth $74831.35 Million With CAGR of 22.27% By 2024 | Segmented by Product Type, Top Manufacturers, By End-User... - January 25th, 2021
- Immunotherapy Inches Forward in Development of Myeloid Malignancies - OncLive - January 14th, 2021
- Cytovia Therapeutics Partners with National Cancer Institute to Develop Novel Gene-Edited, iPSC-Derived GPC3 CAR NK Cells for the Treatment of Solid... - January 14th, 2021
- Kaleido Biosciences Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-to-Moderate COVID-19 - BioSpace - January 14th, 2021
- Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID - CBS San Francisco - January 9th, 2021
- Mana joins the hectic fight against solid tumors with an 'off-the-shelf' candidate angling for an IND this year - Endpoints News - January 9th, 2021
- Versiti Blood Centers and Noodles & Company Serve Up Thanks to Blood Donors - PRNewswire - December 31st, 2020
- Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -... - December 31st, 2020
- 2020 health care year in review - Crain's Cleveland Business - December 31st, 2020
- Gut microbiota: How does it interact with the brain? - Medical News Today - December 31st, 2020
- Numerous Indian American STEM Researchers Named Fellows of American Association for the Advancement of Sciences - India West - December 31st, 2020
- Four years after devastating spinal injury, former St. Paul's football player reunites with caregivers - NOLA.com - December 24th, 2020
- New Combination Therapy Tested By Children's May Offer Hope For Leukemia Patients - WVXU - December 24th, 2020
- Real-time observation helpful in Stem cell for vascular diseases: Study - Hindustan Times - December 21st, 2020
- NurOwn May Be Given to Early ALS Patients in US Who Finished Phase... - ALS News Today - December 21st, 2020
- Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology - Bio-IT World - December 21st, 2020
- Explained: Process of transporting stem cell from donor to patient for a successful transplant - Firstpost - December 18th, 2020
- Research That Saves Lives: Four COVID-19 Therapies Being Tested at UVA - University of Virginia - December 18th, 2020
- Even if You've Had COVID-19 You Still Need the Vaccine - Healthline - December 18th, 2020