PIK3CA News

FDA Approval

FDA Approves Inavolisib, With Palbociclib and Fulvestrant, for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative Advanced Breast Cancer

10/10/2024

Allison Casey ;

The FDA has approved inavolisib, with palbociclib and fulvestrant for patients with endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

The FDA has approved inavolisib,...

10/10/2024

Oncology

News

Adjuvant Aspirin Shows Protective Effect Among Patients With PIK3CA-Mutant Colon Cancer

10/02/2024

Allison Casey ;

The phase 3 SAKK 41/13 trial provides the first prospective data that there is a protective effect with adjuvant advil among patients with resected, PIK3CA-mutant colon cancer.

The phase 3 SAKK 41/13 trial...

10/02/2024

Oncology

News

Evaluating Inavolisib vs Alpelisib Plus Fulvestrant for Hormone Receptor-Positive, HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

09/24/2024

Allison Casey ;

The ongoing INAVO121 trial is open for enrollment of patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer who progressed during or after a CDK4/6-inhibitor–based regimen.

The ongoing INAVO121 trial is...

09/24/2024

Oncology

Conference Coverage

Inavolisib, Palbociclib And Fulvestrant As Potential New Standard of Care for Patients With PIK3CA-Mutated, HR-Positive, HER2-Negative Breast Cancer

12/08/2023

Stephanie Holland

According to primary analysis results from the phase 3 INAVO120 trial, the addition of inavolisib to palbociclib plus fulvestrant significantly improved investigator-assessed progression-free survival in PIK3CA-mutated, hormone...

According to primary analysis...

12/08/2023

Oncology

Recent News

News

Novel EGFR x HER3 Bispecific Antibody-Drug Conjugate Shows Promise Among Heavily-Pretreated Patients With Advanced Urothelial Carcinoma

10/21/2024

Allison Casey ;

A novel EGFR x HER3 bispecific ADC showed encouraging antitumor activity for heavily-pretreated advanced urothelial carcinoma.

A novel EGFR x HER3 bispecific...

10/21/2024

Oncology

News

Amivantamab Plus Chemotherapy Numerically Improved OS for Patients with EGFR-Mutant, Advanced NSCLC

10/21/2024

Allison Casey ;

According to second interim data from the MARIPOSA-2 trial, amivantamab plus chemotherapy numerically improved the overall survival, and significantly prolonged the post-progression outcomes among patients with EGFR-mutant non-small cell lung...

According to second interim data...

10/21/2024

Oncology

FDA Alerts

FDA Approves Zolbetuximab Plus Chemotherapy for Patients With HER2-Negative Gastric/Gastroesophageal Junction Adenocarcinoma With CLDN18.2-Positive Tumors

10/18/2024

Stephanie Holland ;

Based on results from the SPOTLIGHT and GLOW trials, the FDA has approved first-line zolbetuximab plus fluoropyrimidine and platinum-containing chemotherapy for patients with locally advanced, unresectable, or metastatic HER2-negative gastric...

Based on results from the...

10/18/2024

Oncology

Conference Coverage

First-Line Abemaciclib Plus Endocrine Therapy Improves Efficacy Among Patients With HR-Positive, HER2-Negative Advanced Breast Cancer

10/18/2024

Stephanie Holland ;

Results from the phase 2 ABIGAIL trial demonstrated that first-line abemaciclib plus endocrine therapy improves efficacy compared to standard chemotherapy among patients with HR-positive, HER2-negative advanced breast cancer.

Results from the phase 2 ABIGAIL...

10/18/2024

Oncology

FDA Approval

FDA Approves Tumor Treating Fields Wearable Device for Patients With Metastatic Non-Small Cell Lung Cancer

10/17/2024

Allison Casey ;

On October 15, 2024, the FDA granted approval to the Optune Lua, a wearable device that delivers Tumor Treating Fields, for treatment of patients with metastatic non-small cell lung cancer.

On October 15, 2024, the FDA...

10/17/2024

Oncology

News

Treatment With 131L-Apamistamab Before AlloHCT Demonstrates Efficacy, Safety Among Older Patients With R/R AML

10/15/2024

Amber Denham ;

According to phase 3 results from the SIERRA trial, anti-CD45 radioconjugate 131I-apamistamab was well-tolerated and showed a higher durable complete remission rate than standard care among older patients with relapsed/refractory acute...

According to phase 3 results...

10/15/2024

Oncology

FDA Approval

FDA Approves Inavolisib, With Palbociclib and Fulvestrant, for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative Advanced Breast Cancer

10/10/2024

Allison Casey ;

The FDA has approved inavolisib, with palbociclib and fulvestrant for patients with endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

The FDA has approved inavolisib,...

10/10/2024

Oncology

News

Momelotinib Demonstrates Improved Spleen and Symptom Requirements Among Subgroup of Patients With JAK Inhibitor-Naive Myelofibrosis

10/10/2024

Amber Denham ;

Momelotinib was well-tolerated, improved spleen and symptom responses, and reduced transfusion burden among a subgroup of patients with JAK inhibitor-naive myelofibrosis, determined an analysis of the phase 3 SIMPLIFY-1 study.

Momelotinib was well-tolerated,...

10/10/2024

Oncology

News

Nivolumab, Pomalidomide, and Elotuzumab Combination for Patients With R/R Multiple Myeloma

10/10/2024

Amber Denham ;

Nivolumab plus pomalidomide and dexamethasone plus or minus elotuzumab did not demonstrate a clinical benefit compared with pomalidomide and dexamethasone treatment for patients with relapsed/refractory multiple myeloma, according to phase 3...

Nivolumab plus pomalidomide and...

10/10/2024

Oncology

News

Evaluating Long-Term Efficacy and Safety of AlloSCT Among Patients With Peripheral T-Cell Lymphoma

10/10/2024

Amber Denham ;

While allogeneic stem cell transplantation is the preferred treatment for younger, transplant-eligible patients with relapsed/refractory peripheral T-cell lymphoma, it is currently not recommended as part of first-line consolidation,...

While allogeneic stem cell...

10/10/2024

Oncology