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.

On September 4, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pralsetinib (Gavreto™) for adult patients with metastatic, RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq^®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.   

On September 1, 2020, the U.S. Food and Drug Administration (FDA) designated three of the situations involved in BD’s June 30, 2020, previously announced voluntary recall of several models of its Alaris™ system as class I recalls. Class I recall designation indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death.

On September 1, 2020, the U.S. Food and Drug Administration (FDA) approved azacitidine tablets for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence confirmed that those with immunocompromised systems, including cancer, are at greater risk for serious outcomes or death after contracting the COVID-19 coronavirus.

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. 

Cancer clinical trials often collect patient-reported outcome (PRO) data, but the information is generally used just for that trial. Recognizing the value of making it available to healthcare providers everywhere, in July 2020, the U.S. Food and Drug Administration (FDA) launched Project Patient Voice, a pilot program designed to share clinical trial PROs on an easy-to-access website.

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:

Facilitating the provision of patient-centered care is an ONS priority. But until recently, quality information from the patient’s perspective was limited. This kind of information is often unavailable, limited in its breadth, or solicited from patients too late in the healthcare process, making their experience less understandable than necessary. In response, the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence created a pilot program, called Project Patient Voice, that will make patient-reported symptoms from cancer trials available to the public.

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.

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 June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and 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. 

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. 

On May 8, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of olaparib (Lynparza^®) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)–positive status defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability.

On May 8, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo™) for adult patients with metastatic, RET fusion–positive non-small cell lung cancer (NSCLC); adult and pediatric patients aged 12 or older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; and adult and pediatric patients aged 12 or older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate). This is the first drug approval for RET genetic alterations.

On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta™) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test. It is the first drug approval for this specific patient population and the first targeted therapy for the indication.

On May 1, 2020, the U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. The product allows for subcutaneous dosing of daratumumab. 

On April 29, 2020, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula^®) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. 

On April 9, 2020, the U.S. Food and Drug Administration (FDA) announced that supplies of leucovorin calcium lyophilized powder for injection manufactured by Sagent Pharmaceuticals are currently in shortage. On April 21, the agency expanded the shortage to include supplies manufactured by Fresenius Kabi USA and Teva Pharmaceuticals.

On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica^®) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre™), the first treatment approved for adults with certain types of previously treated advanced cholangiocarcinoma. 

On April 17, 2020, as part of Project Orbis, the U.S. Food and Drug Administration (FDA) approved tucatinib (Tukysa™) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery or have spread to other parts of the body, including the brain, and who have received one or more prior treatments. 

On April 15, 2020, the U.S. Food and Drug Administration (FDA) approved mitomycin (Jelmyto®) for the treatment of adult patients with low-grade, upper-tract urothelial cancer (LG-UTUC). 

On April 8, 2020, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi^®) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. 

On April 3, 2020, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl^®) for the treatment of anemia failing an erythropoiesis-stimulating agent and requiring two or more red blood cell (RBC) units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).  

As the United States combats the COVID-19 coronavirus pandemic, federal agencies like the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) are reassuring specific populations, such as those in the cancer community, that the agency is still patient-centered in its mission.