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FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
In the News
,
Multiple Myeloma
,
Personalized Medicine
Web Exclusives
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.
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Darzalex Combined with Revlimid and Dexamethasone New First-Line Regimen for Patients with Multiple Myeloma Ineligible for Transplant
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
Multiple Myeloma
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT). This approval was granted a priority review and used the Oncology Center of Excellence Real-Time Oncology Review program. This is the sixth indication for daratumumab in multiple myeloma and the second indication for newly diagnosed patients.
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Xpovio Receives FDA Approval for Patients with Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
Multiple Myeloma
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies and did not respond to other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody. The FDA reviewed selinexor using its fast track program, and granted it an orphan drug designation.
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Enfortumab Vedotin Promising Third-Line Option for Metastatic Urothelial Cancer
By
Phoebe Starr
Emerging Therapies
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at ASCO 2019.
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Selective, Small-Molecule DRD2 Antagonist Induces Tumor Regression in Recurrent High-Grade Glioma
By
Wayne Kuznar
Emerging Therapies
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—ONC201, a small-molecule DRD2 antagonist, results in durable tumor regression in adults with recurrent high-grade H3-K27M gliomas, reported lead investigator Isabel Arrillaga-Romany, MD, PhD, Associate Clinical Director, Neuro-Oncology, Massachusetts General Hospital Cancer Center, Boston, at ASCO 2019.
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Autologous Mesothelin-Targeted T-Cells Induce Responses in Pleural Solid Tumors
By
Wayne Kuznar
Emerging Therapies
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—A mesothelin-targeted chimeric antigen receptor (CAR) T-cell immunotherapy demonstrated encouraging antitumor activity in combination with pembrolizumab in patients with mesothelin-associated malignant pleural solid tumors, primarily mesothelioma, who had disease progression after platinum-containing chemotherapy, according to results presented at ASCO 2019.
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Gilteritinib and CX-01 in the Treatment of Patients with Acute Myeloid Leukemia
By
Wayne Kuznar
Leukemia
,
Hematologic Malignancies
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—Gilteritinib (Xospata), a recently approved FLT3 inhibitor, prolonged survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an
FLT3
mutation in the phase 3 ADMIRAL clinical trial. A new analysis presented at ASCO 2019 was focused on the impact of baseline co-mutations and
FLT3-ITD
allelic burden on overall response and on overall survival (OS) in patients with relapsed or refractory AML who received treatment with gilteritinib.
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Fixed-Duration Targeted Therapy with Venetoclax plus Obinutuzumab New Front-Line Standard for Patients with Chronic Lymphocytic Leukemia
By
Phoebe Starr
Hematologic Malignancies
,
Leukemia
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—In the phase 3 CLL14 trial, fixed-duration therapy with the combination of venetoclax (Venclexta) plus obinutuzumab (Gazyva) was superior to the combination of chemotherapy with chlorambucil plus obinutuzumab as front-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities. Kirsten Fischer, MD, Center for Integrated Oncology Cologne-Bonn, University Hospital, Germany, presented the study results at ASCO 2019 and were published simultaneously (Fischer K, et al.
N Engl J Med.
2019;380:2225-2236).
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MONALEESA-7 Sets New Standard of Care for Premenopausal Advanced Breast Cancer: Adding CDK4/6 to Endocrine Therapy Extends Survival
By
Phoebe Starr
Breast Cancer
,
Personalized Medicine
,
Solid Tumors
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor ribociclib (Kisqali) to standard endocrine therapy significantly extended overall survival (OS) compared with endocrine therapy alone in premenopausal women with hormone receptor (HR)-positive,
HER2
-negative advanced breast cancer, according to results of the phase 3 MONALEESA-7 clinical trial presented at ASCO 2019.
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Practice-Changing Results: Olaparib Maintenance Therapy Extends Progression-Free Survival in Metastatic Pancreatic Cancer with Germline BRCA Mutation
By
Phoebe Starr
Pancreatic Cancer
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
Chicago, IL—Maintenance therapy with the targeted drug olaparib (Lynparza) after first-line platinum-based chemotherapy prolonged progression-free survival (PFS) in patients with metastatic pancreatic cancer and a germline
BRCA
mutation, according to results of the phase 3 POLO clinical trial presented at the plenary session at ASCO 2019. Lead investigator Hedy L. Kindler, MD, FASCO, Medical Director, Gastrointestinal Oncology, University of Chicago Medicine, IL, presented the results.
Read Article
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