Astellas Pharma US, Inc. is pleased to announce that the FDA has approved XOSPATA. XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.1 An estimated 37% of AML patients have a FLT3 mutation and […]
On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use. The new indication is as follows: Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not […]
AstraZeneca is pleased to announce that IMFINZI® (durvalumab) injection has been assigned a unique HCPCS code by the Centers for Medicare & Medicaid Services (CMS). Effective for dates of services on or after January 1, 2019, the following code can be used to identify IMFINZI® (durvalumab) when billing across settings of care as noted in […]
Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with HCC who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description […]
Merck is pleased to announce that KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel has been approved by the FDA for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA is also indicated in combination with pemetrexed and platinum chemotherapy for the First-line treatment of patients with metastatic nonsquamous NSCLC, with no […]
Pfizer Inc. (NYSE:PFE) announced 11-5-18 that the U.S. Food and Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or […]
The Centers for Medicare & Medicaid Services (CMS) released the final rule for the Medicare Physician Fee Schedule (MPFS) and Quality Payment Program (QPP) outlining reimbursement changes for 2019. CMS estimates that the overall impact will be a one percent reimbursement cut for the hematology/oncology and radiation/oncology specialties in 2019. Based on feedback from ASCO, significant changes […]
Pfizer announced the FDA approval of TALZENNA® (talazoparib) on October 16, 2018. The following information is for your review: Prescribing Information: click here
ASCO shares the Administration’s goal of achieving lower drug costs but is concerned about some aspects of the proposal. ASCO is analyzing the proposal to determine the impact on patient care and practices. The society will respond to the Administration’s questions and request for feedback included in the proposed model to ensure that changes in […]
On October 31, CMS finalized significant changes to the Home Health Prospective Payment System (PPS) to strengthen and modernize Medicare. Specifically, CMS made changes to improve access to solutions via remote patient monitoring technology, updated payments for home health care with a new case-mix system, begin the new home infusion therapy benefit, and reduce burden. […]
