FDA

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

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.

Access to Investigational Drugs (Fact Sheet)

Access to Investigational Drugs (Fact Sheet)

This fact sheet explains investigational drugs and the process by which cancer patients may obtain them.

FDA Reconsidering Safety Training for Doctors Prescribing Opioids

FDA Reconsidering Safety Training for Doctors Prescribing Opioids

Next week, FDA committee of outside experts will meet to review risk-management plans

Many Hold Incorrect Beliefs About FDA Approval Standards and Breakthrough Therapies

Many Hold Incorrect Beliefs About FDA Approval Standards and Breakthrough Therapies

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Recent survey data indicates that the majority of respondents held incorrect beliefs about both U.S. Food and Drug Administration (FDA) approval standards.

FDA Wants Generic Opioids to Be More Abuse-Deterrent

FDA Wants Generic Opioids to Be More Abuse-Deterrent

In the latest step to combat the epidemic of opioid abuse, U.S. officials urge generic drug makers to make changes to opioids.

Clinicians Respond to New CDC Opioid Guidelines

Clinicians Respond to New CDC Opioid Guidelines

Mainly supportive of guidelines, but concerns include a lack of evidence underlying some new recommendations.

Basic Research Data Pivotal for First FDA Approval of Immunotherapy for Pediatric Cancer

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New research has helped influence the FDA's decision to approve the first immunotherapy for pediatric patients.

Nivolumab  Now FDA Approved for Advanced RCC

Nivolumab Now FDA Approved for Advanced RCC

This newly approved drug operates by targeting the PD-1/PD-L1 cellular pathway.

Ixazomib Approved by FDA for Multiple Myeloma Treatment

Ixazomib Approved by FDA for Multiple Myeloma Treatment

This new oral medication blocks certain enzymes, hindering cancer-cell growth.

FDA Approves Pembrolizumab for Advanced Non-Small-Cell Lung Cancer (NSCLC)

FDA Approves Pembrolizumab for Advanced Non-Small-Cell Lung Cancer (NSCLC)

Approved for use with PD-L1 IHC 22C3 pharmDx test

FDA Approves Combination Therapy to Treat Metastatic Colorectal Cancer

FDA Approves Combination Therapy to Treat Metastatic Colorectal Cancer

The combination pill Lonsurf has been approved for patients with metastatic CRC not responding to other therapies.

Iressa for <i>EGFR</i>&#43; metastatic lung cancer approved by FDA

Iressa for EGFR+ metastatic lung cancer approved by FDA

New companion diagnostic kit can identify candidates

Mechanism discovered for BRAF inhibitor resistance in melanoma

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A novel mechanism has been discovered that can lead melanoma cells to develop resistance to drugs that target the protein BRAF.

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