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FDA Update

Leukemia

FDA Approves Ivosidenib/Azacitidine for Certain Patients With Newly Diagnosed AML

The ASCO Post Staff  /  June 10, 2022

On May 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test in adults aged 75 or older, or who have comorbiditi...

Leukemia

FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia

The ASCO Post Staff  /  June 10, 2022

On May 20, the U.S. Food and Drug Administration approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). AZA-JMML-001 Efficacy was evaluated in AZA-JMML-001 (ClinicalTrials.gov identifier NCT02447666), an international, multicenter, open-l...

Gastroesophageal Cancer
Immunotherapy

FDA Approves Two Nivolumab-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

The ASCO Post Staff  /  June 10, 2022

On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma: Nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-based chemotherapy Nivolumab in combi...

New FDA-Approved Oncology Drugs (2021–2022)

Compiled by Donna Bell  /  June 3, 2022 - Narratives Special Issue

Over the past year (May 2021–May 2022), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. FAM-TRASTUZUMAB DERUXTECAN-NX...

Breast Cancer
Immunotherapy

FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Breast Cancer

The ASCO Post Staff  /  May 25, 2022

On May 4, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. According to the approval, patients had to have received a prior anti-HER2–based regimen either in the m...

Skin Cancer
Immunotherapy

FDA Approves Nivolumab/Relatlimab-rmbw for Unresectable or Metastatic Melanoma

The ASCO Post Staff  /  May 10, 2022

On March 18, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approved treatment is a fixed-dose combination of the LAG-3–blocking antibody relatlimab ...

Lymphoma
Immunotherapy

FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma

The ASCO Post Staff  /  April 25, 2022

On April 1, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta) for adult patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemoimmunotherapy or who experienced relapse within 12 months of first-line chemoimmunotherapy. It is not indicat...

Prostate Cancer

FDA Approves Radioligand for Metastatic Castration-Resistant Prostate Cancer

The ASCO Post Staff  /  April 25, 2022

On March 23, the U.S. Food and Drug Administration approved lutetium Lu-177 vipivotide tetraxetan (Pluvicto) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathwa...

Gynecologic Cancers
Immunotherapy

FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

The ASCO Post Staff  /  April 10, 2022

On March 21, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair–deficient (as determined by an FDA-approved test). Eligible patients have disease p...

Breast Cancer

FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer

The ASCO Post Staff  /  April 10, 2022

On March 11, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemothe...

Hematologic Malignancies

FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia

The ASCO Post Staff  /  March 25, 2022

On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a no...

Multiple Myeloma
Immunotherapy

FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma

The ASCO Post Staff  /  March 25, 2022

On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...

Legislation

Robert M. Califf, MD, MACC, Confirmed as FDA Commissioner

The ASCO Post Staff  /  March 10, 2022

On February 15, the Senate voted 50 to 46 to confirm Robert M. Califf, MD, MACC, as Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf was previously the Commissioner of the FDA from February 2016 to January 2017. He also served as the FDA’s Deputy Commissioner for Medical Prod...

Skin Cancer

FDA Approves Tebentafusp-tebn for the Treatment of Unresectable or Metastatic Uveal Melanoma

The ASCO Post Staff  /  February 25, 2022

On January 26, the U.S. Food and Drug Administration (FDA) granted approval to tebentafusp-tebn (Kimmtrak) for the treatment of adult patients with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma. Tebentafusp’s approval establishes several firsts: as the first T-cell receptor therap...

Supportive Care
Hematologic Malignancies

FDA Approves Abatacept-Based Combination for Prophylaxis of Acute Graft-vs-Host Disease

The ASCO Post Staff  /  January 25, 2022

On December 15, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) for the prophylaxis of acute graft-vs-host disease (GVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients aged 2 years and older undergoing hematopoietic stem cell...

Leukemia
Lymphoma
Immunotherapy

FDA Approves Rituximab Plus Chemotherapy for Several Pediatric Hematologic Malignancies

The ASCO Post Staff  /  December 25, 2021

On December 2, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan) in combination with chemotherapy for pediatric patients (≥ 6 months to < 18 years old) with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, Burkitt-...

Multiple Myeloma

FDA Approves Triplet Therapy for Previously Treated Patients With Relapsed or Refractory Multiple Myeloma

The ASCO Post Staff  /  December 25, 2021

On November 30, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with carfilzomib (Kyprolis) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therap...

Gynecologic Cancers

FDA Approves Pafolacianine to Help Identify Ovarian Cancer Lesions

The ASCO Post Staff  /  December 25, 2021

On November 29, the U.S. Food and Drug Administration (FDA) approved pafolacianine (Cytalux), a targeted fluorescent imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug, which is indicated for use in adult patients with ovarian cancer and is administered in the ...

FDA Approves Maribavir for Posttransplant CMV

The ASCO Post Staff  /  December 25, 2021

On November 23, the U.S. Food and Drug Administration (FDA) approved the antiviral maribavir (Livtencity) for adult and pediatric patients aged 12 years and older (and weighing at least 35 kg) with posttransplant cytomegalovirus (CMV) infection or disease that is not responsive (with or without gene...

Skin Cancer
Immunotherapy

FDA Approves Pembrolizumab for the Adjuvant Treatment of Stage IIB or IIC Melanoma

The ASCO Post Staff  /  December 25, 2021

On December 3, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.  KEYNOTE-716 Efficacy was evaluated in KEYNOTE-716, a multice...

Solid Tumors

FDA Approves Sirolimus Protein-Bound Particles for Rare Sarcoma

The ASCO Post Staff  /  December 10, 2021

On November 22, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (albumin-bound; Fyarro) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).  AMPECT Trial Efficac...

COVID-19

FDA Expands Eligibility for COVID-19 Vaccine Boosters

The ASCO Post Staff  /  December 10, 2021

On November 19, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals aged 18 years and older after completion of primary vaccination with any ...

Kidney Cancer
Immunotherapy

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

The ASCO Post Staff  /  December 10, 2021

On November 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of disease recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.  KEY...

Leukemia
Genomics/Genetics

FDA Approves Asciminib for Philadelphia Chromosome–Positive CML

The ASCO Post Staff  /  November 25, 2021

On October 29, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor asciminib (Scemblix) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with two or more tyrosine kinas...

COVID-19

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children Aged 5 Through 11 Years

The ASCO Post Staff  /  November 25, 2021

On October 29, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children aged 5 through 11 years. The authorization was based on the FDA’s thorough and transparent evaluation of the data that in...

Breast Cancer

FDA Approves Abemaciclib in Combination With Endocrine Therapy for Early Breast Cancer

The ASCO Post Staff  /  November 10, 2021

On October 12, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer wh...

Lung Cancer
Immunotherapy

FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC

The ASCO Post Staff  /  November 10, 2021

On October 15, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as d...

Leukemia
Immunotherapy

FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL

The ASCO Post Staff  /  November 10, 2021

On October 1, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ZUMA-3 Efficacy was evaluate...

Gynecologic Cancers
Immunotherapy

FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer

The ASCO Post Staff  /  November 10, 2021

On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as determ...

Colorectal Cancer

FDA Expands Cetuximab Label for Encorafenib Combination in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer

The ASCO Post Staff  /  October 25, 2021

The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for the EGFR inhibitor cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, aft...

FDA Grants Accelerated Approval to Mobocertinib for Patients With Metastatic NSCLC and EGFR Exon 20 Insertion Mutations

The ASCO Post Staff  /  October 25, 2021

� On September 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has progr...

Breast Cancer

Recent FDA Approvals in Breast Cancer

The ASCO Post Staff  /  October 10, 2021 - Supplement: Breast Cancer Almanac

In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibit...

Lymphoma

FDA Grants Zanubrutinib Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

The ASCO Post Staff  /  October 10, 2021

On September 15, zanubrutinib (Brukinsa), a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK), received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one...

COVID-19

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

The ASCO Post Staff  /  October 10, 2021

The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose to be administered at least 6 months after completion of the primary series in individuals aged 65 years and older; ind...

Thyroid Cancer

FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer

The ASCO Post Staff  /  October 10, 2021

On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth f...

Hematologic Malignancies
Symptom Management

Ruxolitinib Granted FDA Approval for Chronic Graft-vs-Host Disease

The ASCO Post Staff  /  October 10, 2021

On September 22, the U.S. Food and Drug Administration approved ruxolitinib (Jakafi), a JAK inhibitor, for the treatment of chronic graft-vs-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older. REACH3 Efficacy was evalua...

Gynecologic Cancers
Immunotherapy

FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

The ASCO Post Staff  /  October 10, 2021

On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...

Breast Cancer
Immunotherapy

Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer

The ASCO Post Staff  /  September 25, 2021

Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast ca...

Solid Tumors
Immunotherapy

FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors

The ASCO Post Staff  /  September 25, 2021

On August 17, 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 solid tumors, as determined by an FDA-approved test, who have had disease progr...

Lymphoma

FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

The ASCO Post Staff  /  September 25, 2021

On August 31, the U.S. Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa), a Bruton’s tyrosine kinase inhibitor, for adult patients with Waldenström’s macroglobulinemia. ASPEN Trial Zanubrutinib was investigated in ASPEN (ClinicalTrials.gov identifier: NCT03053440), a randomized, ...

Bladder Cancer
Immunotherapy

FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma

The ASCO Post Staff  /  September 25, 2021

On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label upda...

Hepatobiliary Cancer

FDA Approves Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma

The ASCO Post Staff  /  September 10, 2021

On August 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo), a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), for adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved ...

COVID-19

FDA Grants Approval to the Pfizer-BioNTech COVID-19 Vaccine

The ASCO Post Staff  /  September 10, 2021

On August 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals aged 16 years and older. The vaccine also co...

Bladder Cancer
Immunotherapy

FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

The ASCO Post Staff  /  September 10, 2021

On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant trea...

Kidney Cancer
Immunotherapy

FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma

The ASCO Post Staff  /  September 10, 2021

On August 10, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). CLEAR Trial The efficacy of this combination was investigated in CLEAR (...

Breast Cancer
Immunotherapy

FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage Triple-Negative Breast Cancer

The ASCO Post Staff  /  August 25, 2021

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

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab and Hyaluronidase-fihj With Pomalidomide and Dexamethasone for Pretreated Patients With Multiple Myeloma

The ASCO Post Staff  /  August 10, 2021

On July 9, 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 proteasom...

Hematologic Malignancies

FDA Approves Belumosudil for Chronic Graft-vs-Host Disease

The ASCO Post Staff  /  August 10, 2021

On July 16, the U.S. Food and Drug Administration (FDA) approved belumosudil (Rezurock), a kinase inhibitor, for adult and pediatric patients aged 12 years and older with chronic graft-vs-host disease after failure of at least two prior lines of systemic therapy. KD025-213 Efficacy was evaluated i...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin-ejfv Granted Regular Approval in Treatment of Locally Advanced or Metastatic Urothelial Cancer

The ASCO Post Staff  /  August 10, 2021

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platin...

Gynecologic Cancers
Immunotherapy

Pembrolizumab/Lenvatinib Granted Regular Approval for Advanced Endometrial Carcinoma

The ASCO Post Staff  /  August 10, 2021

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). These patients must have ...

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