Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
Entrectinib Is Approved for Pediatric Patients with NTRK+ Solid Tumors
The FDA has approved entrectinib to treat pediatric patients ages 1 month and older with NTRK-positive solid tumors.
Pembrolizumab/Chemotherapy is Approved for Neoadjuvant and Adjuvant Resectable Non-Small Cell Lung Cancer
The FDA has approved pembrolizumab with platinum-containing chemotherapy for patients with resectable non–small cell lung cancer, in both the neoadjuvant and adjuvant setting.
Mobocertinib Will No Longer Be Available in US for EGFR Exon 20 Insertion+ NSCLC
Takeda has announced that they will be voluntarily withdrawing mobocertinib for patients with EGFR exon 20 insertion mutation-positive non–small cell lung cancer.
FDA ODAC Panel Votes Against Sotorasib Data in KRAS G12C+ Advanced NSCLC
The FDA Oncologic Drugs Advisory Committee voted 10-to-2 that findings from the phase 3 CodeBreaK 200 trial cannot be reliably interpreted.
Benmelstobart Plus Anlotinib Shows Survival Benefit in ES-SCLC
The benmelstobart combination reduced the risk of death by 39% vs placebo plus chemotherapy in patients with extensive-stage small cell lung cancer.
FDA Approves Momelotinib to Treat Myelofibrosis With Anemia
The FDA has approved momelotinib (Ojjaara) for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.
Iruplinalkib Produces Longer PFS Than Crizotinib in Advanced ALK+ NSCLC
The median progression-free survival with iruplinalkib was 27.70 months vs 14.62 months with crizotinib.
Selpercatinib Boosts Progression-Free Survival in RET-Mutant Medullary Thyroid Cancer
Selpercatinib led to improved progression-free survival in patients with advanced or metastatic RET-mutant medullary thyroid cancer.
FDA Grants Priority Review Designation to Enzalutamide for High-Risk nmCSPC
The FDA has granted enzalutamide priority review designation based on data from the phase 3 EMBARK trial.
FDA Approves FoundationOne CDx as a Companion Diagnostic for Niraparib Plus Abiraterone Acetate in BRCA+ mCRPC
FoundationOne CDx is a next-generation sequencing–based in vitro diagnostic device developed to detect substitutions, insertion, and deletion alterations using 1 tissue sample.
Liso-Cel Leads To High Overall Response Rate in Relapsed/Refractory Follicular Lymphoma
Third-line lisocabtagene maraleucel induced a response in 97% of patients with relapsed or refractory follicular lymphoma.
Fruquintinib Under Priority Review for Patients With Previously Treated mCRC
The FDA has launched a priority review of fruquintinib as treatment for adult patients with previously treated metastatic colorectal cancer.
Frontline Pembrolizumab Plus Axitinib Continues To Show Benefits in Advanced ccRCC at 5-Year Follow-Up
A 5-year analysis of the phase 3 KEYNOTE-426 trial showed continued benefit with pembrolizumab plus axitinib for patients with advanced treatment-naïve clear cell renal cell carcinoma.
FOLFOX Demonstrates Comparable Efficacy to Chemoradiation for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Preoperative FOLFOX demonstrated noninferior efficacy outcomes vs preoperative chemoradiation in locally advanced rectal cancer.
Third-Line GEN-002/Avelumab Elicits Clinical Activity in PD-L1+ Gastric Cancer
Manufacturers believe that GEN-002/avelumab holds promise as a third-line option for patients with gastric cancer and PD-L1 expression.
Lumisight Breast Cancer Detection Device Receives Priority Review Status
The FDA has granted priority review status to a breast cancer optical imaging agent, Lumisight.
Minimally Invasive Distal Pancreatectomy Proves Noninferior to Open Distal Pancreatectomy in Resectable Pancreatic Cancer
Minimally invasive distal pancreatectomy was a safe and effective alternative compared with open distal pancreatectomy in patients with resectable pancreatic cancer.
Capivasertib Demonstrates Potential PFS Advantage in HR+ Advanced Breast Cancer
Combined treatment with capivasertib plus fulvestrant yielded a 5.5-month median progression-free survival for patients with HR+ advanced breast cancer.
Cemiplimab Granted Full Approval For Metastatic Basal Cell Carcinoma
Cemiplimab has received full approval for patients with metastatic basal cell carcinoma. The most common adverse events include fatigue, musculoskeletal pain, rash, diarrhea, and anemia.
Trifluridine/Tipiracil, Plus Bevacizumab Under Priority Review for Refractory mCRC
Trifluridine plus tipiracil, with or without bevacizumab, has been granted priority review status for the treatment of refractory, metastatic colorectal cancer.
Adjuvant Atezolizumab/Bevacizumab Shows Recurrence-Free Survival Benefit Over Active Surveillance in HCC
Combined adjuvant treatment with atezolizumab and bevacizumab was determined to deliver a statistically significant recurrence-free survival benefit to patients with resected hepatocellular carcinoma.
Taletrectinib Shows Promising Response Rates and Intracranial Responses in Select Patients with ROS1+ NSCLC
Patients with TKI-naïve and crizotinib-pretreated ROS-positive non–small cell lung cancer continued to show responses to treatment with taletrectinib.
Ibrutinib is No Longer Available for Mantle Cell Lymphoma or Marginal Zone Lymphoma in the United States
AbbVie has withdrawn the indications for previously pretreated patients with mantle cell lymphoma and marginal zone lymphoma.
Amivantamab Shows Continued Efficacy Following Platinum Treatment in Patients With EGFR Exon 20 Insertion+ NSCLC
Patients with non-small cell lung cancer harboring exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy continued to show responses to amivantamab in a long-term analysis of the CHRYSALIS trial.
Vaginal/Vulvar Symptoms Show Improvement With Lasofoxifene in Postmenopausal Women With ER+/HER2–, ESR1-Mutated Breast Cancer
Lasofoxifene may be helpful in managing vaginal/vulvar symptoms in women with estrogen receptor–positive/HER2-negative breast cancer harboring an ESR1 mutation.
Firstline Nivolumab/Chemotherapy Continues To Outperform Chemotherapy Alone for Advanced Gastric/GEJ/Esophageal Cancer At 3-Year Follow-Up
In an all-randomized population of patients with advanced gastric cancer, gastroesophageal junction, or esophageal adenocarcinoma, adding nivolumab to chemotherapy yielded a 21% reduction in the risk of death.
Nadofaragene Firadenovec Gets Go-Ahead in High-Risk Non–Muscle Invasive Bladder Cancer
The FDA has approved nadofaragene firadenovec-vncg for patients with high-risk non-muscle invasive bladder cancer.
Mosunetuzumab Gets Green Light for Adults With Relapsed/Refractory Follicular Lymphoma
Mosunetuzumab is now an FDA approved treatment for patients with relapsed or refractory follicular lymphoma who have already undergone 2 or more lines or systemic therapy.
Atezolizumab Gets Green Light in Alveolar Soft Part Sarcoma
Atezolizumab has been granted FDA approval for patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.
Ponatinib Outperforms Imatinib in Newly Diagnosed Philadelphia Chromosome+ Acute Lymphoblastic Leukemia
Combining ponatinib with reduced-intensity chemotherapy elicited a high rate of minimal residual disease (MRD)-negative complete remissions and no new safety signals in patients with Philadelphia chromosome–positive acute lymphoblastic leukemia.
Cilta-cel Demonstrates 99.4% ORR in Lenalidomide-Refractory Myeloma
Multidisciplinary Infrastructure Streamlines Cancer Care During Drug Shortages
Workflow, Educational Tools Improve Use of Silicone Film to Prevent Radiation Dermatitis
Inconsistent Symptom Clusters Warrant Routine Assessments in Older Patients With Cancer