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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Padcev Receives Regular FDA Approval for Locally Advanced or Metastatic Urothelial Cancer
FDA Approvals, News & Updates
,
Urothelial Cancer
August 2021, Vol 12, No 4
On
July 9, 2021
, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have received ≥1 previous lines of therapy.
Read Article
Pembrolizumab plus Lenvatinib Combination Receives Regular Approval for Advanced Endometrial Carcinoma
FDA Approvals, News & Updates
August 2021, Vol 12, No 4
On
July 21, 2021
, the FDA granted full approval for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), in combination with the kinase inhibitor lenvatinib (Lenvima; Eisai), for the treatment of advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair-deficient), in patients whose disease progressed after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.
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FDA Approves Darzalex Faspro plus Pomalyst and Dexamethasone for Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
August 2021, Vol 12, No 4
On
July 9, 2021
, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), in combination with pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous line of therapy, including lenalidomide (Revlimid) or a proteasome inhibitor.
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Truseltiq Receives FDA Approval for the Treatment of Patients with Metastatic Cholangiocarcinoma Harboring FGFR2 Alterations
Cholangiocarcinoma
,
FDA Approvals, News & Updates
August 2021, Vol 12, No 4
On
May 28, 2021
, the FDA accelerated the approval of infigratinib (Truseltiq; QED Therapeutics), an oral kinase inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) and
FGFR2
fusion or other rearrangement, as detected by an FDA-approved test. The FDA granted infigratinib priority and fast-track review, as well as orphan drug designation for this indication.
Read Article
Rylaze FDA Approved as Part of a Treatment Regimen for Leukemia or Lymphoma
FDA Approvals, News & Updates
,
Leukemia
,
Lymphoma
August 2021, Vol 12, No 4
On
June 30, 2021
, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to
Escherichia coli
–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication.
Read Article
Lumakras First FDA-Approved Therapy for Advanced or Metastatic NSCLC with KRAS G12C Mutation
FDA Approvals, News & Updates
,
Lung Cancer
June 2021, Vol 12, No 3
On
May 28, 2021
, the FDA accelerated the approval of sotorasib (Lumakras; Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after ≥1 systemic therapies. The FDA granted sotorasib orphan drug and breakthrough therapy designations.
Read Article
Rybrevant First FDA-Approved Therapy for NSCLC with EGFR Exon 20 Insertion Mutations
FDA Approvals, News & Updates
,
Lung Cancer
June 2021, Vol 12, No 3
On
May 21, 2021
, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the
EGFR
and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with
EGFR
exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication.
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Keytruda Received FDA Approval for First-Line Treatment of HER2-Positive Advanced Gastric Cancer
FDA Approvals, News & Updates
,
Gastric Cancer
June 2021, Vol 12, No 3
On
May 5, 2021
, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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Zynlonta First FDA-Approved CD19-Directed Therapy for Large B-Cell Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
June 2021, Vol 12, No 3
On
April 23, 2021
, the FDA accelerated the approval of loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA), an intravenous, CD19-directed antibody and alkylating agent conjugate, for the treatment of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, in adults who have received ≥2 lines of systemic therapy.
Read Article
Opdivo First FDA-Approved Immunotherapy for First-Line Treatment of Advanced Gastric Cancer
FDA Approvals, News & Updates
,
Gastric Cancer
June 2021, Vol 12, No 3
On
April 16, 2021
, the FDA approved the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma. Nivolumab was the first immunotherapy approved by the FDA for first-line treatment of gastric cancer.
Read Article
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