FDA Approvals

FDA Approval

FDA Approves Pembrolizumab Plus Chemoradiotherapy for Patients With Stage III to IVA Cervical Cancer

01/15/2024

Stephanie Holland

Based on results from the KEYNOTE-A18 trial, the FDA has approved pembrolizumab plus chemoradiotherapy for patients with FIGO 2014 Stage III to IVA cervical cancer.

Based on results from the...

01/15/2024

Oncology

Recent News

News

Post-Transplantation Cyclophosphamide vs ATG for GVHD Prophylaxis Among Patients Undergoing Allogeneic Stem Cell Transplant From Mismatched Unrelated Donors

07/02/2024

Amber Denham ;

A retrospective analysis demonstrated that post-transplantation cyclophosphamide yielded survival and non-relapse mortality benefit compared to anti-thymocyte globulin treatment for GVHD prophylaxis among patients undergoing allogeneic stem...

A retrospective analysis...

07/02/2024

Oncology

News

Study Findings Show Considerable Disease Burden of NF1-PN Among Affected Patients

07/01/2024

Janelle Bradley ;

Findings from the real-world CASSIOPEA study show the considerable disease burden of neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) highlighting the importance of effective treatments for this patient population.

Findings from the real-world...

07/01/2024

Oncology

News

Vinblastine/Methotrexate Fails to Demonstrate Activity for NF1-PN in Pediatric and Young-Adult Patients

07/01/2024

Janelle Bradley ;

Findings from a phase 2 study show vinblastine/methotrexate did not demonstrate activity for neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) in pediatric and young-adult patients, despite being well-tolerated.

Findings from a phase 2 study...

07/01/2024

Oncology

News

07/01/2024

Janelle Bradley ;

Study findings show neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) worsens adult patient and caregiver health-related quality of life vs that of the general population.

Study findings show...

07/01/2024

Oncology

FDA Approval

FDA Approves New Formulation of Thiotepa for Patients With Breast and Ovarian Cancer

07/01/2024

Stephanie Holland ;

The FDA has approved the new drug application for SH-105, a liquid formulation of thiotepa, for the treatment of patients with breast and ovarian cancer.

The FDA has approved the new...

07/01/2024

Oncology

FDA Approval

FDA Approves Epcoritamab for Relapsed/Refractory Follicular Lymphoma

06/26/2024

The FDA granted accelerated approval to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory follicular lymphoma who received ≥2 prior lines of therapy.

The FDA granted accelerated...

06/26/2024

Oncology

Conference Coverage

Erdafitinib Shows Promising Clinical Efficacy, Safety Among Pre-Treated Patients With FGFR-Altered Non-Small Cell Lung Cancer

06/26/2024

Stephanie Holland ;

According to results from the phase 2 RAGNAR study, erdafitinib demonstrated promising clinical activity among pre-treated patients with non-small cell lung cancer (NSCLC) harboring pre-specified FGFR alterations.

According to results from the...

06/26/2024

Oncology

News

Iomab-B Led Allogeneic Hematopoietic Cell Transplantation vs Standard of Care for Older Patients With R/R AML

06/25/2024

According to data from the 2024 EHA Congress, long-term results of the phase 3 SIERRA trial demonstrated that conditioning and induction with 131I-apamistamab (Iomab-B) was well-tolerated and allowed for access to HCT with curative potential...

According to data from the 2024...

06/25/2024

Oncology

News

Olutasidenib Demonstrates Efficacy for Patients With R/R IDH1-Mutated AML Previously Treated With Venetoclax

06/24/2024

Olutasidenib treatment demonstrated efficacy and a consistent safety profile for patients with relapsed/refractory mutant IDH1 acute myeloid leukemia previously treated with venetoclax, according to a subset analysis from a phase 2 study.

Olutasidenib treatment...

06/24/2024

Oncology

News

FDA Grants Accelerated Approval to Adagrasib With Cetuximab for Patients With KRAS G12C-Mutated Colorectal Cancer

06/21/2024

Based on results from the KRYSTAL-1 trial, the FDA has granted accelerated approval to adagrasib with cetuximab for patients with KRAS G12C-mutated colorectal cancer.

Based on results from the...

06/21/2024

Oncology