Gina Columbus

Articles

Frontline Ibrutinib/Venetoclax Combo Leads to High Rates of Undetectable MRD in CLL

December 8th 2019

The first-line combination of ibrutinib (Imbruvica) and venetoclax (Venclexta) led to a 75% undetectable minimal residual disease rate in peripheral blood and 72% in bone marrow in patients with chronic lymphocytic leukemia.

Acalabrutinib Alone or in Combination Improves PFS in Frontline CLL

December 7th 2019

Acalabrutinib (Calquence) as a single agent or in combination with obinutuzumab (Gazyva) significantly improved progression-free survival compared with obinutuzumab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia.

Idecabtagene Vicleucel Meets ORR Endpoint in Relapsed/Refractory Multiple Myeloma

December 7th 2019

Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was associated with a 73.4% overall response rate in patients with relapsed/refractory multiple myeloma, meeting the primary endpoint of the pivotal phase II KarMMA trial.

Nadofaragene Firadenovec Meets Complete Response Endpoint in High-Grade NMIBC

December 7th 2019

The investigational gene therapy nadofaragene firadenovec demonstrated a 3-month complete response rate of 53% in patients with high-grade, Bacillus Calmette-Guérin–unresponsive, non-muscle invasive bladder cancer with carcinoma in-situ with or without concomitant high-grade Ta or T1 papillary disease, meeting the primary endpoint of a phase III trial.

Landgren Previews Pivotal ASH 2019 Myeloma Data

December 6th 2019

Ahead of the 2019 ASH Annual Meeting, C. Ola Landgren, MD, PhD, shares insight on the potentially practice-changing data in the multiple myeloma paradigm that will be discussed at the conference.

FDA Panel to Review Olaparib Application in Metastatic Pancreatic Cancer

December 6th 2019

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib tablets as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.

Olaparib Approved in China for Frontline Maintenance in Ovarian Cancer

December 5th 2019

China’s National Medical Products Administration has granted marketing authorization for olaparib as a first-line maintenance treatment for adult patients with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy.

FDA Grants Abatacept Breakthrough Designation for Acute GVHD

December 5th 2019

The FDA has granted a breakthrough therapy designation for abatacept for the prevention of moderate-to-severe acute graft-versus-host disease in patients who have undergone hematopoietic stem cell transplants from unrelated donors.

FDA Approves Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel for Nonsquamous NSCLC

December 4th 2019

The FDA has approved atezolizumab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer who do not harbor EGFR or ALK molecular aberrations.

Sacituzumab Govitecan TNBC Application Resubmitted to FDA

December 4th 2019

Immunomedics has resubmitted its biologics license application to the FDA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease.

Trastuzumab Biosimilar Ogivri Launches in United States

December 3rd 2019

The trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) has been launched in the United States for all indications of the reference product, including the treatment of patients with HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

UK Expands Olaparib Maintenance Indication in Ovarian Cancer

December 3rd 2019

The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease responded to platinum-based chemotherapy and harbor BRCA1/2 mutations.

FDA Schedules ODAC Meeting on Tazemetostat for Epithelioid Sarcoma

December 3rd 2019

The FDA has scheduled an Oncology Drugs Advisory Committee hearing for December 18, 2019, to discuss data supporting a new drug application for tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery.

NICE Approves Palbociclib Combo for HR+ Advanced Breast Cancer

December 3rd 2019

The UK National Institute for Health and Care Excellence has approved palbociclib in combination with fulvestrant for the treatment of female patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.

FDA Grants Pembrolizumab Priority Review for High-Risk NMIBC

December 2nd 2019

The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

Enzalutamide Gains Approval in China for mCRPC

November 28th 2019

China’s National Medical Products Administration has granted approval to enzalutamide for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic following progression on androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

FDA Grants Priority Review to Pemigatinib for FGFR2+ Cholangiocarcinoma

November 27th 2019

The FDA has granted a priority review to a new drug application for pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

Pembrolizumab Regimen Approved in China for Frontline Squamous NSCLC

November 27th 2019

China’s National Medical Products Administration has approved the combination of pembrolizumab plus carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non–small cell lung cancer.

Vorasidenib, Ivosidenib Show Encouraging Activity in IDH1-Mutant Low-Grade Glioma

November 26th 2019

Single-agent vorasidenib or ivosidenib led to brain penetrance and 2-hydroxyglutarate suppression in patients with low-grade glioma who harbor IDH1 mutations.

Chinese Trastuzumab Biosimilar Demonstrates Equivalency in HER2+ Breast Cancer

November 25th 2019

The Chinese-manufactured trastuzumab biosimilar HLX02 demonstrated similar objective response rates to the reference product at 24 weeks in patients with treatment-naïve or recurrent metastatic HER2-positive breast cancer.