FDA Approves FoundationOne®CDx as a Companion Diagnostic for Niraparib and Abiraterone acetate

On August 14, the US Food and Drug Administration (FDA) approved FoundationOne®CDx to be used as a companion diagnostic for Janssen Biotech, Inc. AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).

For more information read the Foundation Medicine Inc. announcement.

Posted 8/15/2023

FDA Grants Accelerated Approval to Elranatamab-bcmm for Multiple Myeloma

On August 14, the US Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm, a bispecific B-cell maturation antigen directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

For more information read the FDA announcement and Pfizer announcement.  

Posted 8/15/2023

FDA Approves Niraparib and Abiraterone acetate + Prednisone for BRCA-mutated mCRPC

On August 11, the US Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.

For more information read the FDA announcement and the Janssen announcement. 

Posted 8/15/2023

FDA Approves Olaparib with Abiraterone and Prednisone (or Prednisolone) for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

For more information read the FDA announcement.

Posted 6/22/2023

FDA Approves Talazoparib + Enzalutamide for HRR Gene-mutated Metastatic Castration-resistant Prostate Cancer

On June 20, the US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer. 

For more information read the FDA announcement and the Pfizer announcement.

Posted 6/21/2023

FDA Approves Olaparib + Abiraterone and Prednisone for BRCA-mutated Metastatic Prostate Cancer

On May 31, the U.S Food and Drug Administration (FDA) approved olaparib with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

For more information read the FDA announcement.

Posted 5/31/2023

FDA Approves Avapritinib for the Treatment of Adult Patients with Indolent Systemic Mastocytosis

Blueprint Medicines is pleased to announce that AYVAKIT® (avapritinib) is now approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with indolent systemic mastocytosis (ISM). ISM is a rare mast cell disease that can lead to the proliferation and activation of abnormal mast cells which can affect multiple organ systems.1,2 ISM is driven by the KIT D816V mutation in about 95% of cases. It can be characterized by a range of symptoms, including skin, gastrointestinal, neurocognitive, and systemic symptoms (including anaphylaxis).2,6-8.

AYVAKIT is a tyrosine kinase inhibitor designed for the potent and selective inhibition of KIT D816V—the only FDA-approved treatment to selectively target the underlying driver of disease in ~95% of patients with ISM.3-5,9.

INDICATION

AYVAKIT® (avapritinib) is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).

Limitations of Use: AYVAKIT is not recommended for patients with platelet counts of <50 x 109/L.

IMPORTANT SAFETY INFORMATION

There are no contraindications for AYVAKIT.

Intracranial Hemorrhage (ICH)—Serious ICH may occur with AYVAKIT treatment; fatal events occurred in <1% of patients. No events of ICH occurred in the 246 patients with ISM who received any dose of AYVAKIT in the PIONEER study. Monitor patients closely for risk factors of ICH which may include history of vascular aneurysm, ICH or cerebrovascular accident within the prior year, concomitant use of anticoagulant drugs, or thrombocytopenia. Symptoms of ICH may include headache, nausea, vomiting, vision changes, or altered mental status.

Advise patients to seek immediate medical attention for signs or symptoms of ICH. Permanently discontinue AYVAKIT if ICH of any grade occurs.

Cognitive Effects—Cognitive adverse reactions can occur in patients receiving AYVAKIT and occurred in 7.8% of patients with ISM who received AYVAKIT + best supportive care (BSC) versus 7.0% of patients who received placebo + BSC; <1% were Grade 3. Depending on the severity, withhold AYVAKIT and then resume at the same dose, or permanently discontinue AYVAKIT.

Photosensitivity—AYVAKIT may cause photosensitivity reactions. In all patients treated with AYVAKIT in clinical trials (n=1049), photosensitivity reactions occurred in 2.5% of patients. Advise patients to limit direct ultraviolet exposure during treatment with AYVAKIT and for one week after discontinuation of treatment.

Embryo-Fetal Toxicity—AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective method of contraception during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Advise women not to breastfeed during treatment with AYVAKIT and for 2 weeks after the final dose.

Adverse Reactions—The most common adverse reactions (≥10%) in patients with ISM were eye edema, dizziness, peripheral edema, and flushing.

Drug Interactions—Avoid coadministration of AYVAKIT with strong or moderate CYP3A inhibitors or inducers. To report suspected adverse reactions, contact Blueprint Medicines Corporation at 1-888-258-7768 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to see the full Prescribing Information for AYVAKIT.

Posted 5/24/2023

FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Mobocertinib

On May 4, the U.S. Food and Drug Administration (FDA) approved the FoundationOne^®Liquid CDx to be used as a companion diagnostic for mobocertinib, which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.

For more information, read the Foundation Medicine announcement. 

Posted 5/4/2023

Novartis ribociclib only Category 1 preferred first-line treatment option for HR+/HER2- mBC in combination with an AI in updated NCCN Clinical Practice Guidelines in Oncology

East Hanover, March 28, 2023 — Updates to the NCCN Guidelines® for breast cancer, released in January 2023, recommend ribociclib (Kisqali®) as the only Category 1 preferred CDK4/6 inhibitor (CDK4/6i) for first-line treatment of patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC) when combined with an aromatase inhibitor (AI). This recommendation indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment.

NCCN Guidelines also continue to recommend ribociclib (Kisqali) plus fulvestrant as a Category 1 preferred regimen for first- and subsequent-line therapies* in HR+/HER2- mBC.

The latest NCCN Guidelines recommend ribociclib (Kisqali) for demonstrating significant overall survival (OS) benefit in combination with various endocrine therapies across three Phase III MONALEESA trials in HR+/HER2- mBC and uniquely in combination with an AI in the first-line setting in MONALEESA-2. These recent updates to the guidelines reinforce key distinctions among the CDK4/6i in mBC, driving the potential to enhance patient access to the latest evidence-based care and to improve outcomes.

In addition to consistently demonstrating statistically significant OS benefit, Kisqali preserved or improved patients’ quality of life in all three Phase III MONALEESA trials.

For more information read the Novartis announcement.

Posted 5/4/2023

FDA Approves Enfortumab Vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

On April 3, U.S the Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

For more information read the FDA announcement, the Merck announcement and the Seagen announcement. 

Posted 4/3/2023