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FDA Approvals, News & Updates
FDA Approvals, News & Updates
FDA Accelerates Approval of Akeega, the First Dual-Action Tablet for BRCA-Mutated Metastatic Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
October 2023, Vol 14, No 5
On
August 11, 2023
, the FDA accelerated the approval of the fixed-dose combination of niraparib and abiraterone acetate (Akeega; Janssen Biotech), with prednisone, for the treatment of adults with deleterious or suspected deleterious
BRCA
-mutated, castration-resistant prostate cancer, as determined by an FDA-approved test. The FDA granted this approval priority review.
Read Article
Gavreto Receives Regular Approval for Patients With RET-Positive NSCLC
FDA Approvals, News & Updates
,
Lung Cancer
October 2023, Vol 14, No 5
On
August 9, 2023
, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type
RET
and oncogenic
RET
fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) and
RET
fusion–positive gene mutation, as detected by an FDA-approved test.
Read Article
FDA Approves Columvi for Select Patients With Relapsed or Refractory Large B-Cell Lymphomas
FDA Approvals, News & Updates
,
Lymphoma
,
Hematologic Malignancies
August 2023, Vol 14, No 4
On
June 15, 2023
, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy.
Read Article
Epkinly FDA Approved for Treatment of Advanced Diffuse Large B-Cell Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
,
Hematologic Malignancies
August 2023, Vol 14, No 4
On
May 19, 2023
, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy.
Read Article
Lonsurf Receives New Indication, in Combination With Bevacizumab, for Previously Treated Metastatic Colorectal Cancer
FDA Approvals, News & Updates
,
Colorectal Cancer
August 2023, Vol 14, No 4
On
August 2, 2023
, the FDA approved a new indication for trifluridine and tipiracil (Lonsurf; Taiho Oncology), in combination with bevacizumab (Avastin), for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti–vascular endothelial growth factor biologic therapy; and if
RAS
wild-type, an anti–epidermal growth factor receptor therapy.
Read Article
Jemperli Plus Chemotherapy Now FDA Approved for Front-Line Treatment of dMMR or MSI-H Endometrial Cancer
FDA Approvals, News & Updates
,
Endometrial Cancer
,
Gynecologic Cancer
August 2023, Vol 14, No 4
On
July 31, 2023
, the FDA approved a new indication for dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
Read Article
Vanflyta Now Approved for Newly Diagnosed FLT3-ITD–Positive AML
FDA Approvals, News & Updates
,
Leukemia
,
Hematologic Malignancies
August 2023, Vol 14, No 4
On
July 20, 2023
, the FDA approved quizartinib (Vanflyta; Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that is
FLT3
-internal tandem duplication (
ITD
)–positive, as detected by an FDA-approved test.
Read Article
Talzenna Receives New Indication, With Enzalutamide, for Metastatic Castration-Resistant Prostate Cancer With HRR Gene Mutation
FDA Approvals, News & Updates
,
Prostate Cancer
August 2023, Vol 14, No 4
On
June 20, 2023
, the FDA approved a new indication for talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase inhibitor, in combination with enzalutamide (Xtandi; Astellas) for homologous recombination repair (
HRR
) gene mutation–positive, metastatic castration-resistant prostate cancer. The FDA granted this application priority review.
Read Article
Tornado Sweeps Through Pfizer’s Storage and Manufacturing Facility
FDA Approvals, News & Updates
Web Exclusives
On July 19, 2023, an EF3 tornado touched down in Rocky Mount, NC, badly damaging a Pfizer drug manufacturing facility that is responsible for producing nearly 25% of Pfizer’s sterile injectable medicines used in US hospitals.
Read Article
Zynyz Receives FDA Accelerated Approval for Merkel-Cell Carcinoma
FDA Approvals, News & Updates
,
Skin Cancer
April 2023, Vol 14, No 2
On
March 22, 2023
, the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz; Incyte Corporation), a programmed cell death 1–blocking antibody, for the treatment of adult patients with metastatic or recurrent locally advanced Merkel-cell carcinoma.
Read Article
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Home
Issues
Online First
Latest Issue
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Personalized Medicine
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Conference Correspondent
SABCS 2023 - HER2+ MBC
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