FDA

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.

FDA and partners crack down on sale of illegal meds

FDA and partners crack down on sale of illegal meds

International effort takes aim at more than 1,050 websites that sell fraudulent medical devices or medications.

ACP encourages ban on flavorings and ads for e-cigarettes

ACP encourages ban on flavorings and ads for e-cigarettes

The ACP has released a position paper suggesting the FDA adopt e-cigarette ad and flavoring bans; backers of devices say bans may drive some smokers back to cigarettes.

FDA greenlights dinutuximab to treat high-risk neuroblastoma

FDA greenlights dinutuximab to treat high-risk neuroblastoma

First approval for a therapy aimed specifically to treat the rare pediatric cancer

First biosimilar drug approved by the FDA

First biosimilar drug approved by the FDA

Zarxio (filgrastim-sndz) is the first biosimilar product approved by the U.S. Food and Drug Administration (FDA) in the United States.

Opdivo approval expanded by FDA to include lung cancer treatment

Opdivo approval expanded by FDA to include lung cancer treatment

FDA approves drug for NSCLC patients who have been treated with platinum-based chemotherapy

Farydak (panobinostat) now FDA-approved for multiple myeloma

Farydak (panobinostat) now FDA-approved for multiple myeloma

Drug is now sanctioned for people who have received at least two prior standard therapies.

Ibrance now FDA-approved to treat advanced breast cancer

Ibrance now FDA-approved to treat advanced breast cancer

Ibrance (palbociclib) has been approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women with ER, HER2-negative metastatic breast cancer.

Opdivo for advanced melanoma approved by FDA

Opdivo for advanced melanoma approved by FDA

Medication helps harness immune system to attack melanoma.

FDA approves lynparza to treat advanced ovarian cancer

FDA approves lynparza to treat advanced ovarian cancer

For advanced ovarian cancer associated with defective BRCA genes

FDA approves Rapivab for acute uncomplicated influenza

FDA approves Rapivab for acute uncomplicated influenza

The U.S. Food and Drug Administration (FDA) has approved RAPIVAB, an intravenous neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older.

New drug improves survival in patients with non-small cell lung cancer

New drug improves survival in patients with non-small cell lung cancer

The FDA has approved a new drug to treat non-small-cell lung cancer (NSCLC), offering patients new hope in fighting this difficult disease.

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