FDA

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

FDA Grants Approval to Idhifa for Some Patients With Acute Myeloid Leukemia

FDA Grants Approval to Idhifa for Some Patients With Acute Myeloid Leukemia

For adults with relapsed or refractory AML who have an IDH2 genetic mutation

Inotuzumab Ozogamicin Granted FDA Approval for Acute Lymphoblastic Leukemia

Inotuzumab Ozogamicin Granted FDA Approval for Acute Lymphoblastic Leukemia

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Inotuzumab ozogamicin (Besponsa), an antibody-drug conjugate comprised of a monoclonal antibody that targets CD22 linked to the cytotoxic agent calicheamicin, was granted FDA approval for the treatment of R/R B-cell precursor ALL.

FDA Expands Ipilimumab Indication to Include Pediatric Unresectable or Metastatic Melanoma

FDA Expands Ipilimumab Indication to Include Pediatric Unresectable or Metastatic Melanoma

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The FDA approved the indication expansion for ipilimumab based on evidence from 2 clinical trials evaluating its safety and efficacy in pediatric patients.

FDA Expands Clearance for Cooling Cap Use With Chemotherapy for Solid Tumors

FDA Expands Clearance for Cooling Cap Use With Chemotherapy for Solid Tumors

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The US FDA has granted expanded clearance for the DigniCap Cooling System to include use in patients undergoing chemotherapy for solid tumors in other areas of the body besides the breast.

Older Adults Under-Represented in Cancer Drug Clinical Trials

Older Adults Under-Represented in Cancer Drug Clinical Trials

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Patients aged 80 years and older had a cancer incidence of 16% in 2013 yet made up only 4% of cancer drug clinical trial participants during 2005-2015.

New Safety Concerns in One-Third of FDA-Approved Drugs 3 Years After Approval

New Safety Concerns in One-Third of FDA-Approved Drugs 3 Years After Approval

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New safety issues are detected in almost one-third of drugs approved by the US FDA in the first 3 years after approval.

Rubraca Granted Accelerated FDA Approval for Advanced BRCA-positive Ovarian Cancer

Rubraca Granted Accelerated FDA Approval for Advanced BRCA-positive Ovarian Cancer

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Rubraca (rucaparib) received accelerated approval by the U.S. Food and Drug Administration for the treatment of patients with previously treated BRCA-positive ovarian cancer.

FDA Grants Priority Review to Ceritinib for First-line Treatment of ALK+ NSCLC

FDA Grants Priority Review to Ceritinib for First-line Treatment of ALK+ NSCLC

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Ceritinib has been granted Priority Review as a first-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.

Excessive FDA Regulation Driving High Drug Prices

Excessive FDA Regulation Driving High Drug Prices

First-in-class drugs are fast-tracked while follow-on drugs can take up to 15 years to be approved by the FDA.

Rucaparib Monotherapy Approved for Advanced Ovarian Cancer

Rucaparib Monotherapy Approved for Advanced Ovarian Cancer

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Rucaparib has been approved for the treatment of patients with advanced ovarian cancer who harbor a deleterious BRCA mutation.

FDA Approves Daratumumab Regimens for Relapsed Multiple Myeloma

FDA Approves Daratumumab Regimens for Relapsed Multiple Myeloma

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The US FDA has granted approval for additional indications for daratumumab for the treatment of patients with multiple myeloma who have received prior therapies.

Atezolizumab Granted FDA Approval for Specific Cases of NSCLC

Atezolizumab Granted FDA Approval for Specific Cases of NSCLC

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Atezolizumab (Tecentriq) is approved by the FDA for the treatment of metastatic NSCLC in specific cases or tumors with EGFR or ALK gene mutations.

Ofatumumab With Fludarabine, Cyclophosphamide Approved for Relapsed CLL

Ofatumumab With Fludarabine, Cyclophosphamide Approved for Relapsed CLL

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The US Food and Drug Administration has approved ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of relapsed chronic lymphocytic leukemia (CLL).

Surrogate End Points Are Poor Predictors of Survival in Cancer Drug Approval

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US FDA standards demand that surrogate end points used in clinical trials be "reasonably likely to predict" survival for accelerated approval, or be established proxies for survival for traditional approval; however, surrogate end points used frequently lack formal study.

FDA Accepts Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Priority Review

FDA Accepts Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Priority Review

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The US FDA has granted Priority Review to ofatumumab used in combination with fludarabine and cyclophosphamide for the treatment of chronic lymphocytic leukemia.

Nutrition Facts Label Redesigned by FDA

Nutrition Facts Label Redesigned by FDA

Added sugars and relevant portion sizes are among the highlights of this food label revision.

Atezolizumab Approved for Locally Advanced or Metastatic Urothelial Carcinoma

Atezolizumab Approved for Locally Advanced or Metastatic Urothelial Carcinoma

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US FDA granted accelerated approval to atezolizumab (TECENTRIQ), indicated for the treatment of locally advanced or metastatic UC in patients whose disease progressed during or following platinum-based chemotherapy, or in the neoadjuvant or adjuvant setting.

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