Drugs

Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). Read more.

Full prescribing information for Opdivo will be posted here.

The Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Read More.

Full Prescribing Information Including Boxed Warning.

Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

The FDA also granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA previously granted accelerated approval for this indication. Read More.

Full prescribing information for Rybrevant will be posted here.

Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. Read More.

Full prescribing information for Amtagvi will be posted here.

Effective for dates of service on or after April 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has assigned the following Healthcare Common Procedure Coding System (HCPCS)* J-Code for ELREXFIO (elranatamab-bccm) injection:

J1323- Injection, elranatamab-bcmm, 1 mg

We are respectfully requesting that you update your membership about this important coding change for ELREXFIO (elranatamab-bccm).

Please see full prescribing information including Boxed Warning, HERE.

Thank you in advance for your consideration and assistance. Please contact me directly If you have any questions or need more information.

* Centers for Medicare and Medicaid Services (CMS)

Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations.

TAGRISSO^® (osimertinib) in combination with pemetrexed and platinum-based chemotherapy was approved by the US Food and Drug Administration (FDA) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Read More.

Please see full Prescribing Information, including Patient Information for TAGRISSO.

Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Read More.

View full prescribing information for Tepmetko.

FDA has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. Read More.

Effective for dates of service on or after January 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has granted ELREXFIO (elranatamab-bccm) injection pass-through status for Hospital OPPS and has assigned the following Healthcare Common Procedure Coding System (HCPCS)* C-Code:

C9165 - Injection, elranatamab-bcmm, 1 mg

We are respectfully requesting that you update your membership about this important coding change for ELREXFIO (elranatamab-bccm).

Please click on the links to see the full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.  Read More.