Drugs

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.

Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy. Read More. 

Full prescribing information for Padcev and Keytruda will be posted here.

Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Read More.

Full prescribing information for Welireg will be posted here.

Food and Drug Administration approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

This represents the first FDA approval of a therapy intended to reduce the risk of relapse in pediatric patients with HRNB. Read More. 

View full prescribing information for IWILFIN.

U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)1. Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). In clinical trials, treatment with Fabhalta increased hemoglobin levels (≥ 2 g/dL from baseline in the absence of RBC transfusions) in the majority of patients and in APPLY-PNH nearly all patients treated with Fabhalta did not receive blood transfusions. Read More.

Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Read More. 

View full prescribing information for Jaypirca.