On September 17, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of all lots of varenicline 0.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, at or above the FDA interim acceptable intake limit. FDA said that while Pfizer is undertaking the precautionary measure, alternative suppliers have been approved in the United States.

On August 9, 2021, the U.S. Food and Drug Administration issued a refuse-to-file letter (RTF) to JD Nova Group, notifying the company that their premarket tobacco product applications associated with approximately 4.5 million of their products do not meet the filing requirements for a new tobacco product seeking a marketing order.

On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity™) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa^®) for adult patients with Waldenström macroglobulinemia (WM).

On August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo^®) for adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. FDA also approved the Oncomine Dx Target Test as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib.

On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 coronavirus infection in individuals aged 16 years and older. The vaccine is still under emergency use authorization (EUA) for individuals aged 12–15 years and as a third dose in certain immunocompromised individuals.

On March 10, 2021, the U.S. Food and Drug Administration approved tivozanib (Fotivda^®), an oral kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk for recurrence after undergoing radical resection.

On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.

On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

American youth reported a decline in using any tobacco product in 2020 compared to 2019 but no significant decrease in the use of cigarettes, hookah, pipe tobacco, or heated tobacco products, according to 2020 U.S. Food and Drug Administration (FDA) survey findings on youth tobacco use. Despite the decline, FDA said that the data shows “disturbingly high rates of frequent and daily e-cigarette use” and strong nicotine dependence among youth.

On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima®) and pembrolizumab (Keytruda®) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg®), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), that do not require immediate surgery.

On August 12, 2021, the U.S Food and Drug Administration (FDA) reported Baxter Healthcare’s recall of the Dose IQ Safety Software used with the Spectrum IQ Infusion System because a software defect may lead to mismatched drug information in drug libraries that were created using version 9.0.x of the computer-based software. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

On August 10, 2021, the U.S. Food and Drug Administration (FDA) reported SterRx, LLC’s, voluntary recall of three lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 ml due to waterborne microbial contamination.

On July 28, 2021, the U.S. Food and Drug Administration (FDA) reported that a clinical trial (OCEAN, Study OP-103) evaluating melphalan flufenamide (Pepaxto®) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. 

On July 26, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and continued as a single agent as adjuvant treatment after surgery. 

Pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (Phesgo^TM) was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for patients with advanced HER2-positive breast cancer. The drug components are the same as those in FDA-approved IV version, and study results showed comparable safety and efficacy to the IV counterparts. The new administration route allows eligible patients to bypass infusion centers or even receive the therapy at home.

On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) in combination with lenvatinib (Lenvima^®) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting, and are not candidates for curative surgery or radiation. 

On July 19, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of two lots of varenicline 0.5 mg tablets, two lots of varenicline 1 mg tablets, and eight lots of a varenicline kit of 9.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. Varenicline is a treatment to help patients quit smoking and is intended for short-term use. To date, Pfizer has not received any reports of adverse events that have been related to the recall.

On July 1, 2021, the U.S. Food and Drug Administration (FDA) reported Teva Pharmaceuticals’ June 30, 2021, voluntary recall of lot 31328962B of topotecan injection 4 mg/4 ml. The recall was based on a report that a single vial contained a glass particle, a grey silicone particle, and a translucent, colorless cotton fiber.

On July 16, 2021, the U.S. Food and Drug Administration (FDA) approved belumosudil (Rezurock^TM), a kinase inhibitor, for the treatment of chronic graft-versus-host disease (chronic GVHD) in adult and pediatric patients 12 years and older after failure of at least two prior lines of systemic therapy. 

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro^®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv ([EV], Padcev®), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

Companies marketing the tobacco brands Aspire, Joyetech, Vaporesso, and Voopoo, which were selected through a systematic process, must share information about social media marketing campaigns that target youth, the U.S. Food and Drug Administration (FDA) announced. The requirements include social media advertising documents and marketing plans, such as planned content to target specific audiences, cost of plans, use of partners and influences, and the number of followers and views broken down by age group.

African Americans have a higher cancer burden and face greater obstacles to cancer prevention, detection, treatment, and survival, according to the American Cancer Society. Health organizations such as ONS and the U.S. Food and Drug Administration (FDA) are dedicated to breaking down barriers and improve access to quality care and resources for those patients. To increase cancer awareness in one of the most vulnerable segments of the U.S. population, the FDA’s Oncology Center of Excellence (OCE) dedicated June 17–23, 2021, as National Black Family Cancer Awareness Week.

On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn (RylazeTM) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. 

On June 16, 2021, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit™) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast cell leukemia.

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to infigratinib (Truseltiq™), a kinase inhibitor for patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test. FDA also approved the FoundationOne^® CDx as a companion diagnostic for infigratinib. 

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™), a RAS GTPase family inhibitor, for adult patients with KRAS G12Cmutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.

On May 27, 2021, the U.S. Food and Drug Administration (FDA) approved piflufolastat F 18 (Pylarify^®), a drug for positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with prostate cancer.

On May 21, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant™), a bispecific antibody directed against epidermal growth factor receptor (EGFR) and MET receptor, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA also approved the Guardant360^® CDx as a companion diagnostic.

On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

The authority to adopt product standards is one of the most powerful tobacco regulatory tools that the U.S. Congress gives the U.S. Food and Drug Administration (FDA). In April 2021, FDA took full advantage of that authority, announcing two new standards to add menthol to the banned flavor list and ban all flavored cigars. 

On May 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda^®) in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta™), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy.

On April 22, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti-PD-1 antibody, for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following treatment with a prior platinum-containing regimen.

On April 16, 2021, the U.S. Food and Drug Administration (FDA) reported Care Fusion 303, Inc.’s, recall of the BD Alaris Pump Module 8100 because the device may experience stuck or unresponsive keys during operation. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

The U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products has aggressively fought to obtain tighter tobacco product regulations to protect adolescent lungs. One of those ways is through premarket review, where e-cigarettes and other new tobacco products that were available as of August 8, 2016, were required to submitted applications to FDA for approval by Sept. 9, 2020.

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

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) issued a safety communication informing patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.

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 19, 2021, the U.S. Food and Drug Administration (FDA) issued an advisory to healthcare professionals not to use ChloraPrep 3 ml applicators manufactured by BD (Becton, Dickinson and Company) because of the risk of microbial contamination. The product was distributed globally and is labeled with “CareFusion, El Paso, TX.”

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.