OPDIVO® (Nivolumab)

The FDA on August 1, 2017 granted accelerated approval to OPDIVO®, for the treatment of patients 12 years and older with MisMatch Repair deficient (dMMR) and MicroSatellite Instability High (MSI-H) metastatic ColoRectal Cancer, that has progressed following treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan. OPDIVO® is a product of Bristol-Myers Squibb Company.

FDA Approves RYDAPT® for FLT3-Mutated Acute Myeloid Leukemia

The FDA on April 28, 2017 approved RYDAPT® (Midostaurin), a multikinase inhibitor, for the treatment of adult patients with newly diagnosed Acute Myeloid Leukemia (AML), who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard Cytarabine and Daunorubicin induction and Cytarabine consolidation. Activating mutations in the FLT3 receptor is the most common genetic abnormality in AML and is detected in approximately 30% of the patients. RYDAPT® along with chemotherapy significantly improved Overall Survival and represents a new standard of care for FLT3-mutated AML patients.

NERLYNX ® (Neratinib)

The FDA on July 17, 2017 approved NERLYNX ® for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant Trastuzumab-based therapy. NERLYNX ® is a product of Puma Biotechnology, Inc.

FDA’s First Tissue/Site-Agnostic Approval

The FDA for the first time approved a cancer treatment based on specific genetic biomarker, rather than location in the body where the tumor originated. KEYTRUDA®, an anti-PD1 monoclonal antibody was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic, MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR ColoRectal Cancer that has progressed following treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan. MMR gene deficiency can be detected by ImmunoHistoChemistry and MSI testing is performed using a PCR based assay.

FDA Approves ENDARI® for Sickle Cell Disease

The FDA on July 7, 2017 approved ENDARI® (L-Glutamine oral powder) for oral administration to reduce the acute complications of Sickle Cell disease, in adult and pediatric patients 5 years and older. There is a higher L-glutamine utilization in Sickle Cell Anemia resulting in its depletion and thereby contributing to oxidative stress. This oxidative stress is an important contributing factor to hemoglobin polymerization, with polymer formation occurring only in the deoxy state. ENDARI® is the first treatment approved for patients with Sickle Cell disease in almost 20 years.

Praxis Extended RAS Panel

The FDA on June 29, 2017 granted marketing approval to the Praxis Extended RAS Panel, a Next Generation Sequencing (NGS) test, to detect certain genetic mutations in RAS genes, in tumor samples of patients with metastatic ColoRectal Cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with VECTIBIX® (Panitumumab). Praxis Extended RAS Panel is offered by Illumina, Inc.

BEVYXXA® (Betrixaban)

The FDA on June 23, 2017 approved BEVYXXA® for the prophylaxis of Venous ThromboEmbolism (VTE) in adult patients hospitalized for an acute medical illness, who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. BEVYXXA® is a product of Portola Pharmaceuticals.

TAFINLAR® and MEKINIST® (Dabrafenib and Trametinib) The FDA on June 22, 2017 granted regular approvals to TAFINLAR® and MEKINIST® administered in combination for patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Inc. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.

The FDA on June 22, 2017 granted regular approvals to TAFINLAR® and MEKINIST® administered in combination for patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Inc. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.

The FDA today also approved the Oncomine™ Dx Target Test (Thermo Fisher Scientific), a Next Generation Sequencing (NGS) test to detect multiple gene mutations for lung cancer in a single test from a single tissue specimen. This test detects the presence of BRAF, ROS1, and EGFR gene mutations or alterations in tumor tissue of patients with NSCLC. This test can be used to select patients with NSCLC with the BRAF V600E mutation for treatment with the combination of TAFINLAR® and MEKINIST®. This is the first NGS oncology panel test approved by the FDA for multiple companion diagnostic indications.