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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Fruzaqla FDA Approved for Relapsed Metastatic Colorectal Cancer
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
November 8, 2023
, the FDA approved fruquintinib (Fruzaqla; Takeda Pharmaceuticals), an inhibitor of
VEGFR
-1
,
-2
, and
-3
, for the treatment of metastatic colorectal cancer (mCRC) in adults who received previous fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if
RAS
wild-type and medically appropriate, an anti-
EGFR
therapy. The FDA granted fruquintinib priority review for this indication.
Read Article
FDA Approved Loqtorzi, a PD-1 Inhibitor, for the Treatment of Metastatic or Recurrent Nasopharyngeal Carcinoma
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
October 27, 2023
, the FDA approved toripalimab-tpzi (Loqtorzi; Coherus BioSciences), a PD-1 monoclonal antibody, in combination with cisplatin and gemcitabine chemotherapy, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma, and as a single agent for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that progressed during or after treatment with a platinum-containing chemotherapy.
Read Article
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of GEJ Adenocarcinoma
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
November 16, 2023
, the FDA approved the use of pembrolizumab (Keytruda; Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic
HER2
-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Read Article
Tibsovo FDA Approved for Patients with Relapsed Myelodysplastic Syndromes and IDH1 Mutation
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
October 24, 2023
, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral tyrosine kinase inhibitor, for the treatment of relapsed or refractory myelodysplastic syndromes (MDS) in adults with a susceptible
IDH1
mutation, as detected by an FDA-approved test.
Read Article
Opdivo Now Approved for Adjuvant Treatment of Stage IIB/C Melanoma
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
October 13, 2023
, the FDA approved a new indication for nivolumab (Opdivo; Bristol-Myers Squibb), a PD-1 inhibitor, for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged ≥12 years. The FDA granted this application an orphan drug designation.
Read Article
Braftovi Plus Mektovi Now FDA Approved for Treatment of Metastatic NSCLC With BRAF Mutation
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
October 11, 2023
, the FDA approved a new indication for encorafenib (Braftovi; Array BioPharma) combined with binimetinib (Mektovi; Array BioPharma) for adults with metastatic non–small cell lung cancer (NSCLC) and a
BRAF
V600E
mutation, as detected by an FDA-approved test.
Read Article
Rozlytrek Now Approved for Pediatric Patients Older Than 1 Month With Solid Tumors and NTRK Gene Fusion and in New Oral Pellet Form
FDA Approvals, News & Updates
December 2023, Vol 14, No 6
On
October 20, 2023
, the FDA accelerated the approval of the tyrosine kinase inhibitor entrectinib (Rozlytrek; Genentech) for the treatment of pediatric patients aged >1 month who are diagnosed with metastatic solid tumors associated with an
NTRK
gene fusion, as detected by an FDA-approved test, and no known acquired resistance mutation or whose disease is likely to lead to severe morbidity and has progressed after previous treatment, or patients who have no satisfactory standard therapy.
Read Article
Hepzato Kit FDA Approved as a Liver-Directed Treatment for Uveal Melanoma With Hepatic Metastases
FDA Approvals, News & Updates
October 2023, Vol 14, No 5
On
August 14, 2023
, the FDA approved melphalan hydrochloride for injection/Hepatic Delivery System (HDS; Hepzato Kit; Delcath Systems) as a liver-directed treatment for use in adults with uveal melanoma and unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease, or extrahepatic disease that is limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
Read Article
FDA Grants Accelerated Approval to Elrexfio for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
October 2023, Vol 14, No 5
On
August 14, 2023
, the FDA accelerated the approval of elranatamab-bcmm (Elrexfio; Pfizer), a bispecific B-cell maturation antigen–directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
Read Article
Talvey Receives Accelerated Approval for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
October 2023, Vol 14, No 5
On
August 9, 2023
, the FDA accelerated the approval of talquetamab-tgvs (Talvey; Janssen Biotech), a bispecific GPRC5D-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
Read Article
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Home
Issues
Online First
Latest Issue
Issue Archive
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Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
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