On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy^®) for patients with locally advanced or metastatic urothelial cancer  who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.

On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy^®) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who received two or more prior systemic therapies, at least one of which for metastatic disease.

On April 6, 2021, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux^®) of 500 mg/m2 via IV infusion for 120 minutes every two weeks for patients with KRAS wild-type, epidermal growth factor receptor-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa^®) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. 

On March 27, 2021, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma), for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma. 

On March 22, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) (tumors with an epicenter 1–5 cm above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. 

On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda^®), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. FDA approved the application three weeks ahead of its goal date.

On March 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta^®) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

On March 3, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena®) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib.

On February 26, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto^®) in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38–directed monoclonal antibody.

On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo^®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation and whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) as determined by an FDA-approved test, with no estimated aberrations to glomerular filtration rate, anaplastic lymphoma kinase, or receptor tyrosine kinase (encoded by the ROS1 gene). 

On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib (Ukoniq™), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.

Tafasitamab-cxix (Monjuvi^®) received accelerated approval from the U.S. Food and Drug Administration in July 2020 in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma.

When used in combination with fulvestrant, alpelisib (Piqray^®) produced complete or partial responses in 29% of patients with PIK3CA-altered, estrogen receptor-positive advanced breast cancer in clinical trials. The U.S. Food and Drug Administration approved it for use in 2019.

In May 2020, the U.S. Food and Drug Administration gave accelerated approval for selpercatinib (Retevmo^®) to treat RET-altered non-small cell lung cancer or thyroid cancer based on overall response rate and duration of response. Selpercatinib fights cancer by impeding RET protein activity. The determining clinical trial results demonstrated that it reduced tumor size in more than 50% of patients and was associated with fewer adverse reactions than other drugs that block the RET protein.

On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for bamlanivimab, an unapproved agent, to treat mild to moderate cases of the COVID-19 coronavirus. EUAs are not FDA approvals; rather, they authorize use of an unapproved medication in an emergency setting. Bamlanivimab’s initial supply is limited, but the manufacturer announced increased production and distribution in early 2021.

On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test. FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic for selecting patients with TNBC for pembrolizumab.

Lohxa, LLC, issued a voluntary recall of five lots of its alcohol-free chlorhexidine gluconate oral rinse USP 0.12% because of a risk that the product may be contaminated with the bacteria Burkholderia lata. The U.S Food and Drug Administration announced the recall on November 9, 2020. 

In June 2020, the U.S. Food and Drug Administration granted accelerated approval to lurbinectedin (Zepzelca^TM) for adults with metastatic small cell lung cancer (SCLC) whose disease has progressed on or after platinum-based chemotherapy. The approval adds a second choice for patients who experience treatment-resistant SCLC progression, who previously had only topotecan as an option.

Zanubrutinib (Brukinsa^TM) received U.S. Food and Drug Administration accelerated approval on November 14, 2019, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Rucaparib (Rubraca^®) has U.S. Food and Drug Administration approval for both maintenance and treatment indications in gynecologic cancers. It originally received accelerated approval in 2016 for the treatment of deleterious, BRCA variant–associated advanced ovarian cancer that has failed two or more chemotherapies. In 2018, it was approved for maintenance therapy of various gynecologic malignancies. Most recently, rucaparib received approval for BRCA-positive metastatic castration-resistant prostate cancer treatment after androgen-directed and chemotherapy.

Starting immunotherapy for bladder cancer shortly after initial treatment with chemotherapy is better than taking an extended break from cancer treatment, according to results from a study reported at the American Society of Clinical Oncology annual meeting.

On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx assay as the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in patients with metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies in one diagnostic test to guide treatment decisions. 

On August 5, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep) for adult patients with relapsed or refractory multiple myeloma who received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

On July 31, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tafasitamab-cxix (Monjuvi^®), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.

On July 30, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.

On July 24, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus™), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi^®) for adult patients with myelodysplastic syndromes, including the following:

On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio^®) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

A new class of drugs, antibody-drug conjugates (ADCs), combines the specificity of targeted therapy with the cytotoxicity of chemotherapy for a powerhouse effect against certain types of cancer variants. Here’s what you need to know about this novel treatment modality.

On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™) via subcutaneous injection for use in combination with docetaxel to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable with surgery or radiation.

On June 22, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio^®) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Viral infections such as HIV may increase a person’s risk for developing several malignancies. However, most investigational drug studies exclude HIV-positive patients with cancer and optimal treatment regimens remain unknown.

On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik™), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, who have received at least two prior systemic therapies and have no satisfactory alternative treatment options.

On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda^®) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and have no satisfactory alternative treatment options.

On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients aged 1 month and older.

On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca™) for adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.

On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza^®) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 mutations. 

On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab plus ipilimumab  and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig^®) for adult patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC). FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib. 

Capecitabine (Xeloda^®) was approved by the U.S. Food and Drug Administration (FDA) in 1998 as a nucleoside metabolic inhibitor with antineoplastic activity indicated for adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer.

On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza^®) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated, metastatic, castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.

On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®) for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 staining ≥ 50% of tumor cells [TC] or PD-L1-stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area), with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. 

On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock™) for adult patients with advanced gastrointestinal stromal tumors (GISTs) who received prior treatment with three or more kinase inhibitors, including imatinib. 

On May 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca^®) for patients with deleterious BRCA mutation (germline or somatic)-associated, metastatic, castration-resistant prostate cancer (mCRPC) who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy. 

On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo^®) and ipilimumab (Yervoy^®) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥ 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 

On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst®) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV negative.