FDA Approves FoundationOne CDx Companion Diagnostic for Selpercatinib in RET+ Solid Tumors
October 10th 2023The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.
Read More
BXCL701 Plus Pembrolizumab Generates Positive OS Data in Small Cell Neuroendocrine mCRPC
October 10th 2023Treatment with the combination of the investigational oral innate immune activator BXCL701 and pembrolizumab led to a median overall survival of 13.6 months in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer.
Read More
MRD Could Guide Venetoclax/Ibrutinib Duration in Previously Untreated, Intermediate-Risk CLL
October 8th 2023The duration of treatment with the combination of venetoclax and ibrutinib could be guided by both toxicities and minimal residual disease kinetics in previously untreated patients with intermediate-risk chronic lymphocytic leukemia, according to interim results from the phase 2 ERADIC trial.
Read More
FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL
October 7th 2023The FDA has placed a partial clinical hold on investigational new drug application for lacutamab, leading to a pause in new patient enrollment for the phase 2 TELLOMAK trial and a phase 1b trial, which are evaluating the agent in patients with advanced cutaneous T-cell lymphoma and peripheral T-cell lymphoma, respectively.
Read More
In a 10-to-2 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the data for progression-free survival per blinded independent central review from the phase 3 CodeBreaK 200 trial evaluating sotorasib vs docetaxel for the treatment of patients with pretreated, locally advanced or metastatic KRAS G12C–mutated non–small cell lung cancer cannot be reliably interpreted.
Read More
First-Line Motixafortide Plus Cemiplimab/Chemotherapy Induces Responses in mPDAC
October 5th 2023First-line treatment with the combination of motixafortide, cemiplimab-rwlc, gemcitabine, and nab-paclitaxel elicited responses in patients with metastatic pancreatic adenocarcinoma, according to initial data from the pilot portion of a phase 2 trial.
Read More
FDA Approves RAS Mutation Detection Kit as Companion Diagnostic for Panitumumab in mCRC
October 5th 2023The FDA has approved the CRCdx® RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer, according to an announcement from EntroGen.
Read More
FDA Grants Fast Track Designation to BI 764532 for ES-SCLC and Extrapulmonary NEC
October 3rd 2023The FDA has granted a fast track designation to BI 764532 for the treatment of patients with extensive-stage small cell lung cancer that has progressed following at least 2 prior lines of treatment, and for patients with advanced or metastatic extrapulmonary neuroendocrine carcinoma that has progressed following at least 1 prior line of treatment.
Read More
PDS0101 Plus Pembrolizumab Elicits 74% 2-Year OS Rate in ICI-Naïve, HPV16+ HNSCC
October 3rd 2023The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.
Read More
Revumenib Meets CR/CRh End Point in KMT2A-Rearranged Relapsed/Refractory AML/ALL
October 2nd 2023Treatment with the first-in-class menin inhibitor revumenib generated complete remissions or complete remissions with partial hematological recovery in adult and pediatric patients with relapsed/refractory acute myeloid leukemia or acute lymphoblastic leukemia harboring KMT2A rearrangements.
Read More
FDA Approves On-Body Injector for Self Administration of Pegcetacoplan for PNH
October 2nd 2023The FDA has approved the Empaveli Injector designed to enhance the self administration of pegcetacoplan, which is approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.
Read More
FDA Grants Priority Review to Odronextamab in Relapsed/Refractory Follicular Lymphoma or DLBCL
September 29th 2023The FDA has granted priority review to the biologics license application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.
Read More
IMNN-001 Plus Neoadjuvant Chemotherapy Improves PFS in Advanced Ovarian Cancer
September 28th 2023Treatment with the interleukin-12 gene-mediated immunotherapy IMNN-001 in combination with neoadjuvant platinum chemotherapy led to an improvement in progression-free survival compared with neoadjuvant chemotherapy alone in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Read More
First-Line Amivantamab Plus Lazertinib Meets PFS End Point in EGFR+ NSCLC
September 28th 2023First-line treatment with the combination of amivantamab and lazertinib resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.
Read More
Isa-KRd Elicits MRD-Negative Remissions in Newly Diagnosed, High-Risk Myeloma
September 27th 2023Treatment with the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone generated high rates of minimal residual disease negativity in patients with newly diagnosed, high-risk multiple myeloma, irrespective of transplant status.
Read More
FDA Approves Bosutinib for Pediatric Ph+ CP-CML
September 27th 2023The 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.
Read More
FDA Grants Fast Track Designation to IDE161 for BRCA+, Platinum-Resistant Advanced Ovarian Cancer
September 26th 2023The 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.
Read More
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.
Read More
Pembrolizumab/Lenvatinib Regimens Miss Survival End Points in Metastatic NSCLC
September 22nd 2023The 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.
Read More
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.
Read More
Perioperative Nivolumab Plus Chemotherapy Improves EFS in Resectable NSCLC
September 22nd 2023Neoadjuvant 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.
Read More
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.
Read More
Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy
September 19th 2023The 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.
Read More
Oral Decitabine and Cedazuridine Wins EU Approval for Newly Diagnosed AML
September 19th 2023The 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.
Read More
FDA Grants Priority Review to Belzutifan in Previously Treated Advanced RCC
September 19th 2023The 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.
Read More