May 19, 2016
In the News
October 28, 2019 – Oncology News & Updates
In This Article Zejula Now Approved for Late-Line Ovarian Cancer Trump Set to Nominate Hahn as FDA Commissioner FDA Aims to Improve Breast Implant Guidance Zejula Now Approved for Late-Line Ovarian Cancer On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment [ Read More ]
Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
In This Article Critical Shortage of Pediatric Cancer Drug Leads to Serious Concerns Study Finds Racial Disparities in Multiple Myeloma Treatment FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-Positive Metastatic Breast Cancer The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study [ Read More ]
Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer
Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to [ Read More ]
First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after [ Read More ]
FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an [ Read More ]
Ivosidenib Now FDA-Approved as First-Line Treatment for AML with IDH1 Mutation
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have [ Read More ]
FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma
On April 19, 2019, the US Food and Drug Administration (FDA) approved a combination of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC), making it the first immunotherapy combination regimen approved for patients with this disease. This application was granted [ Read More ]
April 16, 2019 – FDA Approvals, News & Updates
In This Article FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) On April 11, 2019, the US Food and [ Read More ]
FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based [ Read More ]
Proposed Landmark Policy Changes to Modernize Mammography and Raise Breast Density Awareness
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services. Currently, under the Mammography Quality Standards Act, which [ Read More ]
FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq. On March 18, 2019, the FDA awarded the immunotherapy agent, Tecentriq (atezolizumab; Genentech), in combination with chemotherapy (carboplatin and etoposide), approval for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES-SCLC). [ Read More ]
FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form [ Read More ]
FDA Approves Pembrolizumab for Treatment of Advanced Melanoma
On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first [ Read More ]
FDA Approves Split-Dosing Regimen for Daratumumab in Patients with Multiple Myeloma
On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients [ Read More ]
February 8, 2019 – FDA Approvals, News & Updates
This week, the US Food and Drug Administration (FDA) approved a new drug for a rare blood clotting disorder and alerted healthcare providers to a cancer risk associated with breast implants. In This Article FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder [ Read More ]
February 1, 2019 – FDA Approvals, News & Updates
In This Article FDA Resumes Operations After Government Shutdown Ends FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma FDA Approves Pembrolizumab for Merkel-Cell Carcinoma FDA Resumes Operations After Government Shutdown Ends On Saturday, January 26, 2019, the US Food and Drug Administration (FDA) issued a statement advising all [ Read More ]
Government Shutdown Impacts FDA Drug Approvals
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, [ Read More ]
FDA Approves Portrazza to Treat Advanced Squamous Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Â Â Â Â Â Â Â Â Â Â Â Lung cancer is the leading cause of [ Read More ]
FDA Approves Opdivo to Treat Advanced Form of Kidney Cancer
The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director [ Read More ]
FDA Approves Ninlaro, New Oral Medication to Treat Multiple Myeloma
Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white [ Read More ]
FDA Approves New Pill to Treat Certain Patients with Non—Small-Cell Lung Cancer
New diagnostic test identifies specific gene mutation targeted by new drug Today, the US Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non—small-cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor [ Read More ]
FDA Approves Cotellic as Part of Combination Treatment for Advanced Melanoma
The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K [ Read More ]
FDA Approves First-of-Its-Kind Product for the Treatment of Melanoma
The US Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult [ Read More ]
Keytruda FDA Approved in Patients with Advanced Lung Cancer
The US Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non–small-cell lung cancer (NSCLC) whose disease has progressed after other treatments, and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 [ Read More ]
Nivolumab in Combination with Ipilimumab
On September 30, 2015, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Approval was based on demonstration of an increase in the objective response [ Read More ]