Gina Columbus


FDA Panel Unanimously Supports Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma

July 15, 2020

The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted in favor of the agency approving belantamab mafodotin to treat patients with relapsed or refractory multiple myeloma who have previously received at least four therapies.

Erleada May Extend Subsequent Progression in Men With Castration-Resistant Prostate Cancer

September 28, 2019

Morever, the next-generation androgen receptor improved overall survival, compared with placebo, in patients with nonmetastatic castration-resistant prostate cancer, according to updated findings of the phase 3 SPARTAN trial.

FDA Approves Xpovio to Treat Relapsed/Refractory Multiple Myeloma

July 03, 2019

The Food and Drug Administration has granted an accelerated approval to Xpovio in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received more than four prior therapies.

FDA Approves Frontline Darzalex/Rd in Transplant-Ineligible Myeloma

June 28, 2019

The FDA has approved the combination of Darzalex with Revlimid and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

FDA Grants Priority Review to Zejula for Late-Stage Ovarian Cancer

June 25, 2019

The FDA has granted a priority review designation to a supplemental biologics license application for Zejula for the treatment of certain patients with advanced ovarian, fallopian tube or primary peritoneal cancer.

FDA Approves First Malignant Pleural Mesothelioma Therapy in Over 15 Years

May 24, 2019

The Food and Drug Administration has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the front-line treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.

Food and Drug Administration Panel Supports Pexidartinib for Tenosynovial Giant Cell Tumor

May 14, 2019

The FDA’s Oncologic Drugs Advisory Committee voted in favor of the agency approving pexidartinib to treat adult patients with symptomatic tenosynovial giant cell tumor – a rare, benign lesion that can be locally aggressive and often recurring.

FDA Approves Tibsovo for Frontline IDH1-Mutant Acute Myeloid Leukemia

May 02, 2019

The FDA has approved a supplemental new drug application for Tibsovo as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia who are 75 years and older or are ineligible to receive intensive chemotherapy.

FDA Approves Ibrance to Treat Male Breast Cancer

April 04, 2019

The FDA has expanded the approval of Ibrance (palbociclib) capsules in combination with endocrine therapy for male patients with hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer.

FDA Approves Tecentriq Plus Chemo for Small Cell Lung Cancer

March 19, 2019

The Food and Drug Administration (FDA) has granted an approval to the combination of Tecentriq (atezolizumab) with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

The FDA Approves Fourth Herceptin Biosimilar

March 12, 2019

The Food and Drug Administration (FDA) has granted an approval to Trazimera (PF-05280014; trastuzumab-qyyp), a Herceptin (trastuzumab) biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Approves Cinvanti Injection for Chemotherapy-Induced Nausea and Vomiting

March 02, 2019

The U.S. Food and Drug Administration has expanded the approval of Cinvanti injectable emulsion to include a two-minute intravenous use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.

Erleada Improves Survival in Prostate Cancer Subset

February 01, 2019

In topline findings from the phase 3 TITAN trial (NCT02489318) announced today by Janssen, Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) versus placebo in patients with metastatic castration-sensitive prostate cancer.

FDA Expands Alimta Approval for Use With Immunotherapy and Chemo in Lung Cancer

January 31, 2019

The FDA has expanded the indication for Alimta (pemetrexed) injection in combination with Keytruda (pembrolizumab) and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK alterations.

FDA Approves Third Herceptin Biosimilar

January 19, 2019

The FDA has granted an approval to Ontruzant (SB3; trastuzumab -dttb), a Herceptin (trastuzumab) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

Zanubrutinib Granted Breakthrough Designation for Mantle Cell Lymphoma

January 15, 2019

The Food and Drug Administration (FDA) has granted the investigational BTK inhibitor zanubrutinib (BGB-3111) a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least one prior therapy, according to BeiGene, the company manufacturing the agent.

FDA Approves Frontline Tecentriq Regimen for NSCLC

December 07, 2018

The Food and Drug Administration has approved Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, paclitaxel, the treatment combination known as ABCP, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).

LOXO-292 Granted Breakthrough Designation for Thyroid Cancer

October 15, 2018

The Food and Drug Administration has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have progressed on prior treatment, and have no other acceptable alternative treatment options, according to a statement from Loxo Oncology, the developer of the selective RET inhibitor.

Will Immunotherapy and Radiation Be Combined in Lung Cancer Treatment?

December 27, 2017

Checkpoint inhibitors continue to show promise in the treatment of patients with non-small cell lung cancer (NSCLC), but researchers are now exploring the efficacy of these agents when combined with radiation therapy (RT).