Sabrina Serani

New York

Senior Editor at Targeted Oncology

Senior Editor at MJH Life Sciences

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Articles

FDA Oks Sotorasib/Panitumumab in KRAS G12C-Mutant Colorectal Cancer

Jan 16, 2025 | targetedonc.com | Sabrina Serani |Jordyn Sava

The FDA has approved the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for the treatment of patients with previously treated KRAS G12C-mutated colorectal cancer (CRC). The approval is supported by data from the CodeBreaK 300 (NCT05198934) study. The combination led to improvements in progression-free survival (PFS) and overall response rate (ORR) vs investigator’s choice of standard of care.
Acalabrutinib Plus Bendamustine and Rituximab Receives FDA Approval in MCL

Jan 16, 2025 | targetedonc.com | Sabrina Serani |Jordyn Sava

The FDA has approved acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan; BR) for adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). The supplemental new drug application was granted priority review in October 2024. Findings from the phase 3 ECHO trial (NCT02972840) support the approval.
Paying It Forward: The Importance of Mentorship in a Medical Career

Dec 29, 2024 | onclive.com | Sabrina Serani

For Guillermo Garcia-Manero, MD, mentors have played an invaluable role in his career. It’s why he feels so passionately about being able to provide a similar role to young fellows and physicians through his position as the fellowship program director in the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center (MD Anderson) in Houston.
Durvalumab Wins FDA Approval in Limited-Stage Small Cell Lung Cancer

Dec 4, 2024 | targetedonc.com | Sabrina Serani

The FDA has approved durvalumab (Imfinzi) for the treatment of limited-stage small cell lung cancer (SCLC) that has not progressed following platinum-based concurrent chemoradiotherapy. The approval is supported by the phase 3 ADRIATIC study (NCT03703297). With this approval, a new standard of care is available for this disease state.
FDA Approves Zanidatamab in HER2+ Biliary Tract Cancer

Nov 21, 2024 | targetedonc.com | Sabrina Serani

The FDA granted an accelerated approval to zanidatamab-hrii (Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer. This is the first HER2-targeted treatment specifically approved in this disease state. The approval is supported by data from cohort 1 of the phase 2b HERIZON-BTC-01 trial (NCT04466891).
Checkpoint Inhibition and Targeted Therapy Move the Needle in Anaplastic Thyroid Cancer

Nov 8, 2024 | targetedonc.com | Sabrina Serani

Atezolizumab (Tecentriq) plus targeted therapy demonstrated longer median overall survival (OS) compared with historic controls in patients with anaplastic thyroid cancer, according to findings from a phase 2 study (NCT03181100). These findings warrant the continued investigation of checkpoint inhibition and targeted therapy in this population. “Despite success with BRAF and MEK inhibitors, specifically for BRAF mutation, inevitably resistance occurs.
Sunvozertinib New Drug Application in EGFR-Mutant NSCLC Submitted to FDA

Nov 8, 2024 | targetedonc.com | Sabrina Serani

The new drug application (NDA) of sunvozertinib in relapsed/refractory non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations has been submitted to the FDA. The application is supported by data from the phase 2 WU-KONG1 part B study (NCT03974022). Data from WU-KONG1 part B were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Adding Bevacizumab Improves PFS, But Not OS, in Advanced Biliary Tract Cancer

Nov 6, 2024 | targetedonc.com | Sabrina Serani

The addition of bevacizumab (Avastin) to atezolizumab (Tecentriq) and cisplatin/gemcitabine (CisGem) led to improvements in progression-free survival (PFS) but not overall survival (OS) among patients with advanced biliary tract cancer (BTC), according to findings from the randomized, double-blind, phase 2 IMBrave151 study (NCT04677504).
Phase 1 Study of Type II JAK2 Inhibitor in Myelofibrosis Enrolls First Patient

Nov 4, 2024 | targetedonc.com | Sabrina Serani

A phase 1 clinical trial (NCT06343805) evaluating AJ1-11095, a first-in-class type II JAK2 inhibitor for the treatment of myelofibrosis, has enrolled its first patient.1“There continues to be a significant unmet need for [patients with] myelofibrosis who lose or lack response to existing therapies.
Inavolisib Regimen Continues to Improve Survival in PIK3CA-Mutated Breast Cancer

Nov 1, 2024 | targetedonc.com | Sabrina Serani

Inavolisib (Itovebi) plus fulvestrant and palbociclib (Ibrance) led to a statistically significant and clinically meaningful benefit in progression-free survival (PFS) vs fulvestrant and palbociclib alone in patients with hormone receptor-positive (HR+), HER2-negative (HER2–), PIK3CA-mutated breast cancer, according to the latest data from the phase 3 INAVO120 study (NCT04191499) published in The New England Journal of Medicine.1 The inavolisib regimen reduced the risk of disease progression...