Chris Ryan

Articles

FDA Grants Priority Review to Tovorafenib in Pediatric Relapsed/Progressive Low-Grade Glioma

October 30th 2023

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

FDA Approves Toripalimab for Recurrent or Metastatic Nasopharyngeal Carcinoma

October 27th 2023

The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.

EMA Accepts Marketing Authorization Application for Mirvetuximab Soravtansine in FRα+, Platinum-Resistant Ovarian Cancer

October 27th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FDA Accepts BLA Resubmission for N-803 in BCG-Unresponsive, High-Risk NMIBC In Situ

October 26th 2023

The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

FDA Grants Orphan Drug Designation to TTX101 in Malignant Glioma

October 25th 2023

The FDA has granted an orphan drug designation to TTX101 as a potential therapeutic option for patients with malignant glioma.

Epcoritamab Receives UK Approval for R/R DLBCL After 2 Prior Lines of Therapy

October 24th 2023

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.

Relugolix Wins Approval in Canada for Advanced Prostate Cancer

October 23rd 2023

Health Canada has approved relugolix for the treatment of men with advanced prostate cancer.

Trastuzumab Deruxtecan Wins EU Approval for HER2-Mutated Advanced NSCLC

October 23rd 2023

The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Induction Chemotherapy Prior to Chemoradiation Represents Potential New SOC in Locally Advanced Cervical Cancer

October 22nd 2023

Treatment with platinum-based chemotherapy prior to the administration of chemoradiation led to statistically significant improvements in progression-free survival and overall survival compared with chemoradiation alone in patients with locally advanced cervical cancer.

Second-Line Sacituzumab Govitecan Elicits Responses, Provides Disease Control in ES-SCLC

October 21st 2023

Second-line treatment with sacituzumab govitecan-hziy led to responses in patients with extensive-stage small cell lung cancer, according to results from the phase 2 TROPiCS-03 trial.

Zanubrutinib Receives NICE Recommendation for Treatment of CLL

October 20th 2023

The United Kingdom’s National Institute for Health and Care Excellence has issued a final draft guidance recommending the approval of zanubrutinib for the treatment of adult patients with untreated, high-risk chronic lymphocytic leukemia harboring a 17p deletion or TP53 mutation.

Brentuximab Vedotin Plus AVD Wins EU Approval for Previously Untreated CD30+ Stage III Hodgkin Lymphoma

October 19th 2023

The European Commission has approved brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.

Subcutaneous Nivolumab Meets PK and ORR End Points in Pretreated Advanced or Metastatic ccRCC

October 19th 2023

Treatment with subcutaneous nivolumab co-formulated with recombinant human hyaluronidase demonstrated noninferior pharmacokinetics vs intravenous nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy.

ColoAlert’s Novel mRNA Biomarkers Demonstrate Sensitivity, Specificity in Detecting CRC, Advanced Adenoma

October 18th 2023

The novel mRNA biomarkers in the noninvasive ColoAlert® screening test displayed sensitivity and specificity for detecting colorectal cancer and advanced adenomas that could be precursors to CRC.

SLS009 Plus Venetoclax/Azacitidine Displays Activity, Tolerability in Relapsed/Refractory AML

October 17th 2023

The addition of SLS009 to the combination of venetoclax and azacitidine produced anti-leukemic effects and was safe in patients with relapsed/refractory acute myeloid leukemia who did not respond or stopped responding to venetoclax-based therapies.

Neoadjuvant Daromun Elicits RFS Benefit in Locally Advanced, Fully Resectable Melanoma

October 16th 2023

Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.

FDA Grants Priority Review to Osimertinib Plus Chemotherapy for EGFR+ Locally Advanced or Metastatic NSCLC

October 16th 2023

The FDA has granted priority review to the supplemental new drug application seeking the approval of osimertinib in combination with chemotherapy for the treatment of patients with EGFR-mutated locally advanced or metastatic non–small cell lung cancer.

FDA Approves Adjuvant Nivolumab for Completely Resected Stage IIB/C Melanoma

October 14th 2023

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

FDA Approves Companion Diagnostics for Encorafenib/Binimetinib in BRAF V600E+ Metastatic NSCLC

October 13th 2023

The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.

First-Line UV1 Vaccine Plus Pembrolizumab Sustains OS in Unresectable or Metastatic Melanoma

October 12th 2023

First-line treatment with the universal cancer vaccine UV1 in combination with pembrolizumab sustained overall survival in patients with advanced unresectable or metastatic malignant melanoma, according to updated data from cohort 1 of the phase 1 UV1-103 trial.