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Enhertu Gets Tumor-Agnostic FDA Approval for HER2-Positive Cancers

— About half of patients responded, duration of response as long as 19 months in three trials

April 5, 2024 9:00 am

By Charles Bankhead

The FDA granted tumor-agnostic accelerated approval to trastuzumab deruxtecan (Enhertu) for previously treated unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid cancers.

The action represents the first tumor-agnostic approval for an antibody-drug conjugate targeting HER2-positive tumors. According … Read more

Priority Review Granted for Trastuzumab Deruxtecan; Would Be First Tumor-Agnostic ADC

A tumor-agnostic approval would be a significant development in the advance of antibody-drug conjugates (ADCs), which are designed to deliver a potent, cancer-fighting payload into a tumor while sparing nearby tissues.

January 30, 2024 9:00 am

Clearity’s Perspective: Most drugs are tested and approved to treat cancers based on where in the body the cancer started and the type of tissue from which it developed. Enhertu (Trastuzumab Deruxtecan, T-Dxd), a HER2-targeted antibody drug conjugate (ADC), already … Read more

NCCN Guidelines Update Adds Mirvetuximab Soravtansine Plus Bevacizumab for FRα-Expressing, Platinum-Sensitive Ovarian Cancer

January 19, 2024 9:00 am

Clearity’s Perspective: In the January 17, 2024 update to the National Comprehensive Cancer Network (NCCN) guidelines for ovarian cancer, several new therapies have been added to the list of acceptable regimens for recurrent platinum-resistant ovarian cancer. For example, trastuzumab deruxtecan … Read more

Ovarian Cancer: Best Practices for Managing PARP Inhibitor Side Effects

October 4, 2023 9:00 am

Oncologists treating ovarian cancer need to be proactive to prevent or reduce the likelihood of adverse effects associated with poly (ADP-ribose) polymerase (PARP) inhibitors, noted authors of a review in the ASCO Educational Book.

William Tew, MD, of Memorial Sloan … Read more

First Blood Test for Dozens of Hereditary Cancers Approved by FDA

October 2, 2023 9:00 am

The FDA has approved the first blood test that can help identify hundreds of potentially cancer-associated hereditary variants. The Invitae Common Hereditary Cancers Panel evaluates a blood sample to identify DNA variants in 47 genes associated with an elevated risk … Read more

Elahere for Ovarian Cancer: How to Manage Side Effects

August 15, 2023 9:00 am

A new drug approval is providing hope for many people living with ovarian cancer.

Some women have what is known as “platinum-resistant” cancer, that means the disease is no longer responding to platinum-based chemotherapy, the most common chemo drug used … Read more

How to Treat Gynecologic Cancers During the Chemotherapy Shortage

June 12, 2023 6:48 pm

Three organizations have joined together to provide oncologists with recommendations for how to treat patients with gynecologic cancers in light of current chemotherapy shortages.

The recommendations, which pertain to the shortages of cisplatin, carboplatin, and methotrexate, were released by the … Read more

Guideline addresses use of integrative therapies for cancer-related pain management

November 30, 2022 3:07 pm

by Jennifer Byrne

A new clinical practice guideline jointly published by ASCO and Society for Integrative Oncology addresses the potential role of integrative pain management techniques in management of cancer-related pain in adults.

“Patients with cancer, as well as cancer … Read more

FDA Seeks to Restrict Rucaparib to Second-line Maintenance Therapy in Recurrent Ovarian Cancer

November 18, 2022 11:51 am

by Jason Harris

The FDA has asked Clovis Oncology to limit use of rucaparib (Rubraca) to second-line maintenance therapy for patients with recurrent ovarian cancer harboring BRCA mutations.1

The company is considering the FDA’s request. If the 2 sides

… Read more

FDA Approves Mirvetuximab Soravtansine-gynx for FRα+ Platinum-resistant Ovarian Cancer

November 14, 2022 12:21 pm

By Kristi Rosa

The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for the treatment of adult patients with folate receptor α (Frα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior … Read more

FDA Requests Restriction of Second-line Maintenance Niraparib Indication in Ovarian Cancer

November 14, 2022 11:41 am

by Kristi Rosa

At the request of the FDA, GlaxoSmithKline (GSK) plc will restrict the second-line maintenance indication for niraparib (Zejula) to only the population of patients with recurrent ovarian cancer whose tumors harbor deleterious or suspected deleterious germline BRCA

… Read more

ASCO Addresses PARP Controversy in Guideline Update

September 28, 2022 12:01 pm

— A response to “practice-changing data” in the first- and second-line setting

by Mike Bassett

An updated recommendation from the American Society of Clinical Oncology (ASCO) warns against the routine use of PARP inhibitor monotherapy in the second- or later-line

… Read more

FDA Grants First Tumor-Agnostic Approval for RET Fusion-Positive Cancers

September 22, 2022 9:49 am

by Mike Bassett

— Selpercatinib approved for advanced or metastatic solid tumors that progress on systemic therapy

The FDA granted accelerated approval to selpercatinib (Retevmo) for adults with locally advanced or metastatic solid tumors associated with RET gene fusions, the

… Read more

Maintenance Therapy the ‘Biggest Breakthrough in Decades’ for Ovarian Cancer

September 15, 2022 1:54 pm

by Karen Blum

Although maintenance treatments have helped patients with ovarian cancer live longer, experts note there are still some unmet needs that must be addressed.

Karen Hanna was first diagnosed with ovarian cancer in April 2013. At the time,

… Read more

FDA Approves Tafinlar Plus Mekinist for Patients With BRAF V600-Mutant Solid Cancers

June 23, 2022 10:56 am

by Brielle Benyon

Tafinlar plus Mekinist is now approved by the Food and Drug Administration to treat adults and children over the age of 6 who have BRAF V600-mutant advanced solid cancers.

The Food and Drug Administration (FDA) approved Tafinlar

… Read more

Real-World Data Identify Significant Differences in Tolerability Among Approved PARP Inhibitors in Ovarian Cancer

June 14, 2022 11:57 am

by Lindsey Fischer

A real-world analysis showed that the proportion of women with ovarian cancer who required dose modifications or treatment discontinuations while receiving PARP inhibitors differed significantly between olaparib, niraparib, and rucaparib.

Patients with ovarian cancer treated with FDA-approved

… Read more

First-line Niraparib Improves PFS in Ovarian Cancer

May 18, 2022 9:16 am

by Ariana Pelosci

An individualized starting dose of niraparib, determined by weight and platelet count continued to demonstrate a clinical meaningful improvement in progression-free survival in newly diagnosed ovarian cancer in the first-line maintenance setting, regardless of biomarker status.

An

… Read more

MEK Inhibition Is Now a Standard of Care in Recurrent Low-Grade Serous Ovarian Cancer: What Next?

April 25, 2022 12:08 pm

by Rachel N. Grisham, M.D.

As summarized in this issue of The ASCO Post, the highly anticipated results of the GOG 281/LOGS study, which randomly assigned patients with recurrent low-grade serous ovarian cancer to the MEK inhibitor trametinib vs … Read more

Olaparib Dose Reductions/Interruptions Do Not Affect Survival in Platinum-Sensitive Ovarian Cancer

March 11, 2022 10:00 am

by Ariana Pelosci

Adverse effects associated with treatment with olaparib that led to dose reductions and interruptions did not impact survival benefit for patients with platinum-sensitive ovarian cancer.

Patients with platinum-sensitive recurrent ovarian cancer who experienced adverse effects (AEs) during

… Read more

Virtual Surveillance Visits with Symptom, Serum CA-125 Review May Offer Alternative for Ovarian Cancer Recurrence Detection.

February 1, 2022 12:37 pm

by Monica Janke, MD

In patients with ovarian cancer and pretreatment elevated CA-125 who achieved remission after frontline therapy, most recurrences are detected by rising CA-125 levels or symptoms.

In patients with ovarian cancer and pretreatment elevated CA-125 who achieved

… Read more