Drugs

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. 

U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. 

KEYTRUDA is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients. Approval marks third FDA-approved indication for KEYTRUDA in cervical cancer and 39th indication for KEYTRUDA in the US. Read More.

This notification is to inform you that the Compassionate Use Program for EXKIVITY is now open for enrollment in the U.S. The withdrawal of EXKIVITY will occur no later than March 2024, with the specific date still to be determined by the US Food and Drug Administration (FDA) based on review of ongoing operational activities related to the withdrawal.

• Patients prescribed EXKIVITY through March 2024 will be eligible for this Compassionate Use Program. The Compassionate Use Program will provide these patients with product free of charge for as long as they are deriving benefit from the drug, as assessed by their healthcare provider.

• Shipments from the Compassionate Use Program will not begin until withdrawal. Takeda will be coordinating this once enrollment submission has been complete.

• For transparency and in support of addressing questions, a similar letter will be shared with patients currently prescribed EXKIVITY for whom we have contact information on file for. Patients will be directed to speak with their healthcare provider about the Compassionate Use Program and the enrollment process.

As a reminder and until withdrawal, EXKIVITY continues to be available to prescribe for new and existing patients through normal channels for patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. For the U.S. Prescribing Information, including the Boxed Warning, please visit www.exkivity-update.com/prescribing-information.

EXKIVITY will no longer be available for new patients after withdrawal in March 2024.

This is a courtesy communication and there is no action needed on your end.  Updates will also be posted on www.exkivity-update.com.

For additional questions, please contact Takeda at 844-662-8532 between the hours of 8:00am and 6:00pm EST or globaloncologymedinfo@takeda.com.