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.  

On April 1, 2020, the U.S. Food and Drug Administration asked manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). 

On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 coronavirus pandemic in recognition that it may affect the conduct of clinical trials of medical products, including drugs, devices, and biologic products.

Change at the federal level takes time and perseverance. Thanks to great effort from the smoking cessation community—including ONS—the federal government is updating package and advertising warning for tobacco products for the first time since 1984. Advocates have been calling on agencies to exercise authority over tobacco products along with their marketing and distribution, and on March 17, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule requiring new health warning labels for cigarette packages and advertisements.

To address the COVID-19 coronavirus pandemic, on March 22, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

On March 22, 2020, the U.S. Food and Drug Administration took action to increase the availability of ventilators, accessories, and other respiratory devices during the COVID-19 coronavirus pandemic to support patients with respiratory failure or difficulty breathing.

On March 10, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo^® and Yervoy^®) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 

On February 4, 2020, BD announced a recall of all lots of affected models of its Alaris System pump modules because of multiple system errors, software errors, and use-related errors. On March 6, 2020, the U.S. Food and Drug Administration identified it as a class I recall, its most serious level of recalls, because of the possibility of serious injuries or death.

On March 2, 2020, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa^®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

The growing rates of teen vaping and e-cigarette use have been a focal point at the national legislative level for the past several years. From the U.S. surgeon general’s youth vaping epidemic announcement to the investigation of vaping industry leader Juul, congressional representatives have been busy addressing the issue.

On February 25, 2020, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlyn®) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Vaping pens and other electronic smoking devices were branded as step-down strategies to help the 60 million Americans who are unable to quit traditional cigarettes. The U.S. Food and Drug Administration even supported the idea initially, but research eventually showed that vaping products contain the same or higher levels of nicotine as other tobacco products and are equally as addictive.

Despite restrictive legislation raising the age of purchase for tobacco products to 21, vaping remains a top legislative concern, and some believe that vaping restrictions are already out of date. For nearly two decades, youth smoking rates were on the decline. After e-cigarette companies like Juul brought their products to market, those rates have seen a sharp uptick and led the U.S. surgeon general to declare a youth smoking epidemic. Although some progress has been made, the issue remains a top priority for organizations like ONS and its members.