Chris Ryan

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical investigation to provide substantial evidence to support approval

Rucaparib maintenance improved progression-free survival (PFS) in homologous recombination deficiency (HRD)-negative advanced ovarian cancer, irrespective of baseline prognostic factors.

A new drug application (NDA) has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non–small cell lung cancer (NSCLC).

The FDA approved the quadruplet regimen on July 30 for induction and consolidation therapies in patients with newly diagnoses multiple myeloma who are eligible for autologous stem cell transplant.

The FDA has approved durvalumab combined with carboplatin and paclitaxel, followed by single-agent durvalumab.

The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alteration, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

The FDA has approved pembrolizumab (Keytruda) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The European Medicines Agency (EMA) 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.

The FDA has approved the CRCdx RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer (mCRC), according to an announcement from EntroGen.

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 poly-ADP ribose polymerase, or PARP, inhibitor therapies.

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

Second-line treatment with axicabtagene ciloleucel (axi-cel) led to an investigator-assessed, 3-month complete metabolic response rate of 71.0% in patients with large B-cell lymphoma (LBCL) who were ineligible for autologous stem cell transplant.

The phase 3 ENHANCE trial evaluating the first-line combination of magrolimab and azacitidine vs placebo plus azacitidine in patients with higher-risk myelodysplastic syndrome has been discontinued due to futility at a planned analysis.

China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.

The FDA approved the VENTANA PD-L1 assay for expanded use in patients with advanced non–small-cell lung cancer to help identify patients who may be candidates for treatment with cemiplimab.

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.