FDA

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

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

By

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 

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs