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KEYTRUDA® approved by the FDA for the treatment of patients with cSCC that is not curable by surgery or radiation.

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) injection 100 mg has been approved by the FDA for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. • PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients. PD-L1=programmed death ligand […]

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CMS modifies Medicare Medically Unlikely Edit (MUE) Value for KEYTRUDA®

Merck has informed OSCO that the Medicare Medically Unlikely Edit (MUE) value has been modified for KEYTRUDA® (pembrolizumab). The MUE for KEYTRUDA was modified effective July 1, 2020. A list of quarterly Procedure-to-Procedure and MUE version update changes from CMS can be found here. Payer coding and coverage requirements may vary or change over time, so it […]

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KEYTRUDA® Approved by FDA for Additional Indication.

Merck has announced that the FDA has approved KEYTRUDA® (pembrolizumab) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC). MSI-H/dMMR testing is required prior to initiating treatment with KEYTRUDA in these patients. For the MSI-H/dMMR indication, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in […]

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Astellas announces the assignment of a product-specific, permanent J-code for PADCEV.

Astellas has announced the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.1 * Note that the product’s NDC code has been “zero-filled” […]

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ADAKVEO® (crizanlizumab-tmca) J-code J0791 effective 7/1/2020

Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg. The new and unique J-code replaces all previous HCPCS codes for ADAKVEO® (crizanlizumab-tmca) […]

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FDA announces approval of KEYTRUDA® for additional treatments.

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the FDA for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. ·    PD-L1 diagnostic testing is not required prior to […]

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Taiho Oncology announces a new patient assistance program

Taiho Oncology announced that is offering a new patient assistance program where eligible patients pay $0 per treatment plan.  Patients who are reimbursed under Medicaid, a Medicare drug benefit program, Tricare, or other state or federal programs are not eligible.  To determine patient eligibility, go to or call: TaihoOncologyCopay.com or phone (844) TAIHO-4U (844-824-4648).

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LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of […]

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FDA approves ENHERTU® for treatment of adult patients with unresectable or metastatic Her2 positive breast cancer.

Daiichi Sankyo and AstraZeneca announced that the US Food and Drug Administration (FDA) approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response […]

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Pfizer announces new safety information added to the labeling for all CDK4/6 inhibitors, including IBRANCE.

IBRANCE (palbociclib) 125 mg capsules is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men, or fulvestrant in patients with disease progression following endocrine therapy The 5.2 Warnings […]

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