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FDA Updates
Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
By
Lisa A. Raedler, PhD, RPh, Medical Writer
FDA Updates
,
Ovarian Cancer
2018 Third Annual Oncology Guide to New FDA Approvals
In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them.
Read More ›
Olaparib Tablet Receives New Indication in Ovarian Cancer
FDA Updates
TON - September 2017, Vol 10, No 5
On August 17, 2017, the FDA approved a new indication for olaparib, in tablet form, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease completely or partially responded to chemotherapy that was platinum-based, regardless of their
BRCA
mutation status.
Read More ›
Cancer Drug Approvals: A Tale of 2 Views
By
Sharon Donovan
FDA Updates
TON - May 2017, Vol 10, No 3
Following a year in which approximately 2 dozen cancer drugs were approved by the FDA, approvals in 2016 decreased by approximately 50% compared with 2015.
Read More ›
FDA Approvals of Brand-Name Prescription Drugs in 2016
FDA Updates
2017 Second Annual Oncology Guide to New FDA Approvals
The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2016.
Read More ›
Rucaparib Approved with a Companion Diagnostic Test for Patients with Advanced Ovarian Cancer
FDA Updates
TON - January 2017, Vol 10, No 1
On
December 19, 2016
, the FDA granted accelerated approval to rucaparib (Rubraca; Clovis Oncology Inc), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious
BRCA
gene mutation, and who have been treated with ≥2 chemotherapies.
Read More ›
FDA Approves Rucaparib and Companion Diagnostic for Patients with Advanced Ovarian Cancer
FDA Updates
,
In the News
Web Exclusives
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
Read More ›
Daratumumab Combination Approved for Multiple Myeloma
FDA Updates
,
In the News
Web Exclusives
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
Read More ›
Sustol, First Extended-Release 5-HT3 Approved for the Prevention of CINV
FDA Updates
Web Exclusives
On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults.
Read More ›
Cabometyx Receives FDA Approval for Advanced Renal-Cell Carcinoma
FDA Updates
Web Exclusives
On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis) for the treatment of patients with advanced renal-cell carcinoma (RCC) who had received anti-angiogenic therapy.
Read More ›
Olaratumab Approved for Use with Doxorubicin in Adults with Advanced Soft-Tissue Sarcoma
FDA Updates
,
Online First
Web Exclusives
Read More ›
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