FDA

FDA Grants Approval to Novel Treatment for Hairy Cell Leukemia

FDA Grants Approval to Novel Treatment for Hairy Cell Leukemia

Lumoxiti, a CD22-directed cytotoxin, has been approved for adult patients who have had at least two prior therapies for the disease.

Long-Term Azithromycin May Increase Risk of Relapse of Blood Cancers After HSCT

Long-Term Azithromycin May Increase Risk of Relapse of Blood Cancers After HSCT

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US FDA issues a recommendation on use of azithromycin in patients with hematologic malignancies who have undergone HSCT.

Encorafenib, Binimetinib Combination Receives FDA Approval for Mutation-Positive Melanoma

Encorafenib, Binimetinib Combination Receives FDA Approval for Mutation-Positive Melanoma

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Approval was granted for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.

First Antibody-Based Treatment Regimen Approved for First-Line Treatment of Multiple Myeloma

First Antibody-Based Treatment Regimen Approved for First-Line Treatment of Multiple Myeloma

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The 18-month progression-free survival rate was 71.6% among patients treated with daratumumab plus VMP compared with 50.2% among patients treated with VMP alone.

Dual Inhibitor for Treating CLL/SLL, Follicular Lymphoma Granted Priority Review

Dual Inhibitor for Treating CLL/SLL, Follicular Lymphoma Granted Priority Review

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Duvelisib, a first-in-class dual inhibitor of PI3K-delta and -gamma, was evaluated in patients with relapsed/refractory CLL/SLL and in patients with refractory indolent non-Hodgkin lymphoma.

Rucaparib Granted FDA Approval for Some Recurring Abdominal Cancers

Rucaparib Granted FDA Approval for Some Recurring Abdominal Cancers

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The US FDA granted approval based on results from ARIEL3, a randomized clinical trial conducted with 561 eligible cancer patients.

FDA Approves Blincyto for B-Cell Precursor ALL in Remission With MRD Presence

FDA Approves Blincyto for B-Cell Precursor ALL in Remission With MRD Presence

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Accelerated approval was granted by the FDA based on the results of a single-arm trial.

Dabrafenib-Trametinib Combination Approved for Mutation-Positive Thyroid Cancer

Dabrafenib-Trametinib Combination Approved for Mutation-Positive Thyroid Cancer

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FDA grants approval to immunotherapy combination in the treatment of unresectable and metastatic BRAF V600E mutation-positive anaplastic thyroid cancer (ATC).

Recruitment for 2 Trials of Investigational ADC for Urothelial Cancer Underway

Recruitment for 2 Trials of Investigational ADC for Urothelial Cancer Underway

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Enfortumab vedotin was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA), based on interim results from a Phase 1 study.

Fifth Indication for Brentuximab Vedotin Is a First for cHL Therapy in 40+ Years

Fifth Indication for Brentuximab Vedotin Is a First for cHL Therapy in 40+ Years

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FDA approval was granted based on findings from the open-label phase 3 ECHELON-1 study.

Blinatumomab Indications Expanded to Include MRD+-B-Cell Precursor ALL

Blinatumomab Indications Expanded to Include MRD+-B-Cell Precursor ALL

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The US FDA approved expanding the indications for the agent to include pediatric and adult patients with B-cell precursor ALL who have minimal residual disease during or after treatment.

Promising Phase 2 Results Lead to Fast Track Designation for Pancreatic Cancer Drug 

Promising Phase 2 Results Lead to Fast Track Designation for Pancreatic Cancer Drug 

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FDA Fast Track designation was supported by data from a Phase 2 study reviewing pamrevlumab in combination with gemcitabine and nab-paclitaxel.

FDA Expands Nilotinib Indication to Include Pediatric Chronic Myeloid Leukemia

FDA Expands Nilotinib Indication to Include Pediatric Chronic Myeloid Leukemia

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Based on results of 2 prospective studies, the FDA approved the use of nilotinib in pediatric patients older than 1 year with newly diagnosed Ph+ CML-CP and those with TKI-intolerant or resistant disease.

Oral Androgen Receptor Inhibitor Granted FDA Approval for Nonmetastatic CRPC

Oral Androgen Receptor Inhibitor Granted FDA Approval for Nonmetastatic CRPC

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According to the FDA, the drug approval is the first to use the end point of metastasis-free survival.

FDA, ASHP Actions to Prevent or Manage Chemotherapy Drug Shortages

FDA, ASHP Actions to Prevent or Manage Chemotherapy Drug Shortages

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What is being done to address shortages of chemotherapy drugs?

FDA Upgrades Nivolumab to Regular Approval for Adjuvant Treatment of Advanced Melanoma

FDA Upgrades Nivolumab to Regular Approval for Adjuvant Treatment of Advanced Melanoma

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The FDA granted approval for nivolumab for adjuvant treatment of some patients with melanoma, based on the results of the CHECKMATE-238 study.

Priority Review of New Drug Application Granted to Apalutamide for CRPC

Priority Review of New Drug Application Granted to Apalutamide for CRPC

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Data from the phase 3 SPARTAN trial prompted the FDA's Priority Review designation for apalutamide.

FDA Issues Warning for Rolapitant Injectable Emulsion in the Treatment of CINV

FDA Issues Warning for Rolapitant Injectable Emulsion in the Treatment of CINV

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FDA issues black box warning for rolapitant regarding the potential for anaphylaxis, anaphylactic shock, and other hypersensitivity reactions in patients receiving the injectable emulsion for CINV prophylaxis.

Indications for Cabozantinib in Advanced RCC Expanded to First-line Therapy

Indications for Cabozantinib in Advanced RCC Expanded to First-line Therapy

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The FDA based its approval on data collected from the open-label, phase 2 CABOSUN study, for which researchers randomly assigned 157 patients with RCC to receive oral cabozantinib or sunitinib.

FDA Grants Breakthrough Therapy Designation to Ribociclib for HR+/HER2- Breast Cancer

FDA Grants Breakthrough Therapy Designation to Ribociclib for HR+/HER2- Breast Cancer

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FDA grants Breakthrough Therapy designation for ribociclib as an initial endocrine-based therapy for HR+/HER2- breast cancer in premenopausal or perimenopausal women.

Pertuzumab Regimen Approved for Adjuvant, Neoadjuvant Therapy in Specific Breast Cancers

Pertuzumab Regimen Approved for Adjuvant, Neoadjuvant Therapy in Specific Breast Cancers

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The US FDA approved pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of HER2-positive early breast cancer, and converted accelerated to full approval for the regimen as neoadjuvant therapy in certain breast cancers.

FDA Approves Biosimilar Trastuzumab-dkst for Breast and Stomach Cancers

FDA Approves Biosimilar Trastuzumab-dkst for Breast and Stomach Cancers

Ogivri was granted FDA approval to treat HER2 breast and gastric or gastroesophageal junction adenocarcinoma cancers.

Brentuximab Vedotin Granted FDA Approval for pcALCL, Mycosis Fungoides

Brentuximab Vedotin Granted FDA Approval for pcALCL, Mycosis Fungoides

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The US FDA has granted regular approval to brentuximab vedotin (Adcetris) for pcALCL and CD30-expressing MF in adult patients who received prior systemic therapy.

Alectinib Granted FDA Approval as First-line Therapy for <i>ALK</i>-positive NSCLC

Alectinib Granted FDA Approval as First-line Therapy for ALK-positive NSCLC

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Approval was based on results from ALEX, for which researchers randomly assigned 303 patients with ALK-positive NSCLC not previously treated with systemic therapy to receive alectinib or crizotinib.

Vemurafenib Granted FDA Approval as First Drug to Treat Erdheim-Chester Disease

Vemurafenib Granted FDA Approval as First Drug to Treat Erdheim-Chester Disease

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Indications for vemurafenib are expanded to include BRAF V600 mutation-positive Erdheim-Chester disease, an extremely rare non-Langerhans cell histiocytosis. FDA approval is based on results from the phase 2 VE-BASKET study.

FDA Discontinues ESA APPRISE Risk Evaluation and Mitigation Strategy Program

FDA Discontinues ESA APPRISE Risk Evaluation and Mitigation Strategy Program

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Why was the ESA APPRISE risk evaluation and mitigation strategy program discontinued?

Acalabrutinib Approved for Mantle Cell Lymphoma

Acalabrutinib Approved for Mantle Cell Lymphoma

Acalabrutinib is a treatment option for patients with mantle cell lymphoma who have not responded to prior treatment.

FDA Grants Approval to Bevacizumab-awwb as First Biosimilar for Anticancer Therapy

FDA Grants Approval to Bevacizumab-awwb as First Biosimilar for Anticancer Therapy

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Bevacizumab-awwb is a recombinant IgG1 monoclonal antibody that works by binding to vascular endothelial growth factor (VEGF) and inhibits angiogenesis.

FDA Approves Gemtuzumab Ozogamicin for CD-33 Positive Acute Myeloid Leukemia

FDA Approves Gemtuzumab Ozogamicin for CD-33 Positive Acute Myeloid Leukemia

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Gemtuzumab ozogamicin (Mylotarg) was granted US FDA approval for the treatment of relapsed or refractory CD-33 positive AML in patients ages 2 years and older and newly diagnosed CD-33 positive AML in adult patients.

Two FDA Approvals Propel CAR T Cell Therapy Into the Limelight

Two FDA Approvals Propel CAR T Cell Therapy Into the Limelight

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The first FDA approval of a CAR T cell therapy is granted for the treatment of B-cell precursor ALL. FDA also approves rheumatoid arthritis medication for the management of cytokine release syndrome, a common and serious adverse effect of CAR T cell therapy

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