Chris Ryan

Articles

FDA Approves Bosutinib for Pediatric Ph+ CP-CML

September 27th 2023

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy.

ABM-1310 Receives FDA Fast Track Designation for BRAF V600E+ Glioblastoma

September 26th 2023

The FDA has granted fast track designation to ABM-1310 for the treatment of patients with glioblastoma harboring BRAF V600E mutations.

FDA Grants Fast Track Designation to IDE161 for BRCA+, Platinum-Resistant Advanced Ovarian Cancer

September 26th 2023

The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and PARP inhibitor therapies.

First-Line Lutetium Lu 177 Dotatate Plus Octreotide Improves PFS in Advanced Gastroenteropancreatic NETs

September 25th 2023

First-line treatment with lutetium Lu 177 dotatate plus long-acting octreotide led to a statistically significant and clinically meaningful improvement in progression-free survival compared with high-dose long-acting octreotide alone in newly diagnosed patients with somatostatin receptor–positive, grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors.

Pembrolizumab/Lenvatinib Regimens Miss Survival End Points in Metastatic NSCLC

September 22nd 2023

The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.

Enfortumab Vedotin Plus Pembrolizumab Generates Survival Benefit in Previously Untreated Advanced Urothelial Cancer

September 22nd 2023

Treatment with the combination of enfortumab Vedotin and pembrolizumab led to an improvement in overall survival and progression-free survival compared with chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy.

Perioperative Nivolumab Plus Chemotherapy Improves EFS in Resectable NSCLC

September 22nd 2023

Neoadjuvant treatment with nivolumab plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer.

SLS009 Demonstrates Activity, Safety in Relapsed/Refractory Lymphoma

September 21st 2023

Treatment with SLS009 generated clinical activity and was safe in patients with relapsed/refractory lymphomas.

FDA Grants Priority Review to Pembrolizumab Plus Chemoradiotherapy for High-Risk Locally Advanced Cervical Cancer

September 20th 2023

The FDA has granted priority review to a supplemental biologics license application seeking the approval of pembrolizumab in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, for the treatment of newly diagnosed patients with high-risk, locally advanced cervical cancer.

Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy

September 19th 2023

The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Oral Decitabine and Cedazuridine Wins EU Approval for Newly Diagnosed AML

September 19th 2023

The European Commission has approved oral decitabine and cedazuridine for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for standard induction chemotherapy.

FDA Grants Priority Review to Belzutifan in Previously Treated Advanced RCC

September 19th 2023

The FDA has granted priority review to the supplemental new drug application seeking the approval of belzutifan for the treatment of previously treated patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies.

FDA Grants Fast Track Designation to KT-333 in R/R CTCL and PTCL

September 18th 2023

The FDA has granted fast track designation to KT-333 for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma.

CHMP Recommends Against Renewal of Marketing Authorization for Belantamab Mafodotin in R/R Myeloma

September 18th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against renewal of the conditional marketing authorization for belantamab mafodotin-blmf for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior treatments.

Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer

September 18th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.

Adjuvant Pembrolizumab Receives Positive CHMP Opinion for High-Risk NSCLC After Resection and Chemo

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

FDA Extends Priority Review of BLA for Lifileucel in Advanced Melanoma

September 15th 2023

The FDA has extended the priority review period for the biologics license application seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.

FDA Approves New and Updated Indications for Temozolomide in Anaplastic Astrocytoma

September 14th 2023

The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma. Under Project Renewal, the regulatory agency has also revised indications for the treatment of patients with refractory anaplastic astrocytoma.

Golidocitinib NDA Under NMPA Review for Relapsed/Refractory PTCL

September 14th 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of golidocitinib for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

Novel mRNA Biomarker Integration Boosts Sensitivity, Specificity of ColoAlert in Detecting CRC

September 13th 2023

The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer.