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

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

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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

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Anti-cancer drugs, olaparib and adavosertib, work best when given sequentially in patients with advanced tumours driven by DNA damage response mutations: results from Phase Ib STAR clinical trial

October 27, 2022 2:26 pm

Barcelona, Spain: Patients with cancers that are driven by certain mutations occurring in response to DNA damage can be safely treated with two drugs, olparib and adavosertib, if they are given in sequence rather than concurrently.

Presenting results from the … Read more

Elizabeth Swisher, MD, on Predicting Therapy Benefits in Ovarian Cancer

October 5, 2022 4:42 pm

by Mark L. Fuerst

– KELIM score can now be used to look at upfront response, study showed

Tumor primary chemosensitivity testing can help determine if ovarian cancer patients need a boost along with first-line chemotherapy. In the VELIA trial, … 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

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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,

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Niraparib Maintenance Provides Durable Long-term Remission in High-Risk Advanced Ovarian Cancer

September 15, 2022 10:45 am

by Kristi Rosa

Maintenance treatment with niraparib produced a sustained and durable progression-free survival benefit in patients with primary advanced ovarian cancer who responded to first-line platinum-based chemotherapy, spanning biomarker subgroups.

Maintenance treatment with niraparib (Zejula) produced a sustained and

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Maintenance PARP Inhibition Boosts OS in Two Ovarian Cancer Trials

September 9, 2022 10:37 am

by Mike Bassett

— Results from SOLO-1 and PAOLA-1 show “clinically meaningful” long-term results with olaparib

PARIS — Olaparib (Lynparza) maintenance therapy appears to offer a long-term overall survival (OS) benefit for women with ovarian cancer, according to two phase … 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

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First-Line Rucaparib Maintenance Improves PFS in Ovarian Cancer, Regardless of HRD Status

June 6, 2022 9:30 am

by Ariana Pelosci

The ATHENA-MONO trial showed a significant improvement in progression-free survival when patients with platinum-sensitive ovarian cancer were treated with maintenance rucaparib vs placebo in the first-line setting, regardless of HRD status.

Rucaparib (Rubraca) significantly improved progression-free survival

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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

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Olaparib Dosage Can Be Reduced Without Affecting Survival in Ovarian Cancer

April 18, 2022 12:28 pm

by Lindsay Fischer

New research suggests that olaparib treatment interruption or dosage reduction is not linked with inferior survival outcomes in patients with BRCA1/2–mutated, platinum-sensitive, recurrent ovarian cancer.

Patients with BRCA1/–mutated, platinum-sensitive, recurrent ovarian cancer who needed to reduce

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Next-Generation AstraZeneca PARP1 Inhibitor Shows Activity in Multiple Cancers at Variety of Doses

April 12, 2022 1:12 pm

by Alison Kanski

NEW YORK – An investigational AstraZeneca drug that showed activity at a range of doses across differently mutated cancers with limited toxicity exemplifies the versatility of next-generation PARP1 inhibitors, according to researchers at the American Society for … Read more

Maintenance Rucaparib Significantly Improves PFS in Phase 3 ATHENA-MONO Trial for Advanced Ovarian Cancer

March 31, 2022 10:44 am

by Ariana Pelosci

A significant improvement in progression-free survival was observed in the phase 3 ATHENA-MONO trial with first-line maintenance rucaparib vs placebo in patients with advanced ovarian cancer.

Progression-free survival (PFS) was significantly improved with first-line rucaparib (Rubraca) as

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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

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Ovarian Cancer Patients in PARP Inhibitor Trials Don’t Reflect Real-World Population

February 25, 2022 11:33 am

by Jonathan Goodman, MPhil

Hispanic and Non-Hispanic Black patients were significantly underrepresented, but Asian/Pacific Islander patients were overrepresented.

Clinical trials of PARP inhibitors in patients with ovarian cancer do not accurately reflect the racial and ethnic makeup of the real-world … Read more

Rechallenge With PARP Inhibitor Slows Relapsed Ovarian Cancer

September 17, 2021 4:10 pm

— Benefits platinum-sensitive disease irrespective of BRCA, homologous repair status, study showed

Patients with relapsed platinum-sensitive ovarian cancer had significant improvement in progression-free survival (PFS) when retreated with the PARP inhibitor olaparib … Read more

Researchers pinpoint how PARP inhibitors combat BRCA1 and BRCA2 tumor cells

August 13, 2021 9:27 pm

A team of Massachusetts General Hospital (MGH) researchers has discovered how an important class of anti-cancer drugs called PARP inhibitors works, a finding that could help improve treatment and prolong survival for patients with breast cancer and other malignancies.… Read more

Can an Antibiotic Treat Cancers that Become Resistant to PARP Inhibitors?

July 27, 2021 12:44 pm

For a second time, researchers will test an antibiotic discovered in the 1950s as a potential treatment for cancer.

The first attempt to study the drug, novobiocin, in patients with cancer was a small clinical trial conducted 30 years ago. … Read more

Ceralasertib Olaparib Combo Elicits Promising Activity In Parp Resistant Ovarian Cancer

July 15, 2021 2:43 pm

The combination of ceralasertib and olaparib induced clinical activity and was well tolerated in patients with homologous recombination deficient, recurrent platinum-sensitive, PARP inhibitor–resistant ovarian cancer.

The combination of ceralasertib and olaparib (Lynparza) induced clinical activity and was well tolerated in … Read more