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U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant.

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer wit

Tue, 02 Jun 2026 07:00:00 -0400

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne®Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate

With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company1

BOSTON--(BUSINESS WIRE)--

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting

Tue, 02 Jun 2026 01:05:00 -0400

Filing acceptance, under priority review, based on Phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy
Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years
Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early-stage (I-III)
The FDA has set a Prescription Drug User Fee Act date of November 30, 2026

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX:

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting

Tue, 02 Jun 2026 01:05:00 -0400

Filing acceptance, under priority review, based on Phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy
Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years
Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early-stage (I-III)
The FDA has set a Prescription Drug User Fee Act date of November 30, 2026

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX:

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting

Tue, 02 Jun 2026 01:05:00 -0400

Filing acceptance, under priority review, based on Phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy
Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years
Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early-stage (I-III)
The FDA has set a Prescription Drug User Fee Act date of November 30, 2026

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: