The majority of women newly diagnosed with early-stage breast cancer would like to be tested for BRCA1 and BRCA2 mutations, but only a small proportion undergo genetic testing.

The significant PFS advantage was also maintained when just considering patients with a nondeficient status by prospective tumor tissue testing, at an HR of 0.66.

The effect of BRCA on these genomic tests is also unknown.

The authors also note that “[r]egarding biomarker testing to determine the potential to benefit from specific therapies, the Panel limited recommendations to those assays that were evaluated by the FDA in the course of drug approval.”

Describing germline BRCA1/2 testing as “an important companion diagnostic for adjuvant treatment decisions in breast cancer,” the presenter concluded that the US FDA has now approved olaparib for use in patients with these mutations and HER2-negative, high-risk early-stage breast cancer disease after neoadjuvant or adjuvant chemotherapy. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group ESMO Virtual Plenary; 16–17 March 2022

The primary endpoint of independently assessed radiographic progression-free survival (PFS) in the 225 BRCA -mutated patients was significantly longer with the addition of niraparib rather than placebo to abiraterone–prednisone, at a median of 16.6 versus 10.9 months.

André noted in response to a question from the audience that this improvement “was not fully driven” by BRCA 1/2 targeted therapy.

They say their data suggest that “multigene panel testing may be appropriate for women with ILC.”

Genetic testing should be expanded to include older women with breast cancer, especially those with triple-negative or estrogen receptor-negative disease, suggest US researchers.

The OlympiA study has demonstrated a significant reduction in the risk for recurrence and disease progression with adjuvant olaparib versus placebo in patients with HER2-negative, early-stage breast cancer and germline BRCA mutations.

“This population is possibly most reflective of the general CRPC population seen in many centers around the world, where testing for DNA repair gene aberrations may not be available in daily clinical practice,” comment the researchers.

Commenting on the announcement in a press release, Mark Socinski (AdventHealth Cancer Institute, Orlando, Florida, USA) said the approval “helps expand access to important genomic information needed for physicians to make more informed decisions about targeted approaches for their parents and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care.” medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group

“PROfound is the first positive biomarker-selected phase III study evaluating a molecularly-targeted therapy in men with mCRPC, and highlights the importance of genomic testing in this population,” presenter Maha Hussain (Northwestern University, Chicago, Illinois, USA) told delegates at the ESMO Congress 2019 in Barcelona, Spain.

The document also includes recommendations regarding precision medicine, including guidance on germline testing for cancer risk genes and treatment options for men harboring BRCA1 / 2 mutations, and palliative care.

AACR 2020: EMBRACA overall survival analysis finds no benefit for talazoparib vs chemotherapy for BRCA-mutated, HER2-negative advanced breast cancer.