Drugs

Dear Valued Healthcare Partner,

We are informing you that Takeda, following alignment with the U.S Food and Drug Administration, has announced that EXKIVITY (mobocertinib) is no longer commercially available in the U.S. market.

EXKIVITY was previously indicated for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease had progressed on or after platinum-based chemotherapy.

As of April 8, 2024, Takeda will no longer provide EXKIVITY commercially. As previously communicated, Takeda launched a Compassionate Use Program (“Program”) in January to ensure patients on or prescribed EXKIVITY before April 1, 2024 could have access to the drug. Only patients who were prescribed EXKIVITY prior to April 1, 2024 will be eligible for the Program. Healthcare providers have been notified and provided resources to complete Program submission per patient eligibility.

Takeda is committed to our patients and ensuring patients on therapy can continue access. For questions regarding enrollment in the Compassionate Use Program, contact medicineaccess@clinigengroup.com .

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

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

Please see full prescribing information including Boxed Warning, HERE.

1. On March 13, the Cannabis and Cannabinoids in Adults With Cancer: ASCO Guideline was published. Cannabis and/or cannabinoid access and use by adults with cancer has outpaced the science supporting their clinical use. Clinicians should recommend against using cannabis or cannabinoids as a cancer-directed treatment unless within the context of a clinical trial. Cannabis and/or cannabinoids may improve refractory, chemotherapy induced nausea and vomiting when added to guideline-concordant antiemetic regimens. Several tools, including a recommendations table, slides, clinician and patient focused podcasts, a patient summary, and a pocketcard, which is free to ASCO members, accompany the guideline.
2. On March 18, the Vaccination of Adults with Cancer: ASCO Guideline was published. Optimizing vaccination status should be considered a key element in the care of patients with cancer. This approach includes the documentation of vaccination status at the time of the first patient visit; timely provision of recommended vaccines; and appropriate revaccination after hematopoietic stem-cell transplantation, chimeric antigen receptor T-cell therapy, or B-cell–depleting therapy. A recommendations table, slides, podcast, patient summary, fact sheet, and a pocketcard, which is free for ASCO members, are available.
3. On March 19, the Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline Update was published. The guideline provides recommendations for first-line, second-line, and third-line systemic therapy. An algorithm, recommendations table, slides, patient information, podcast, and a pocketcard, which is free to ASCO members, are available

Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. Mirvetuximab soravtansine-gynx previously received accelerated approval for this indication. Read More.

Full prescribing information for Elahere will be posted here.

Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).

Fluorouracil injection was initially approved in 1962. The FDA became aware of additional safety information regarding the risk of serious adverse reactions related to fluorouracil use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Revisions have been made to the Highlights of Prescribing Information and sections 5 (Warnings and Precautions) and 17 (Patient Counseling Information) of the full prescribing information to provide information about these risks. In addition, a new subsection 12.5 (Pharmacogenomics) has been added to section 12 (Clinical Pharmacology). The labeling changes align with those approved for another fluoropyrimidine drug, Xeloda (capecitabine) tablets, on December 14, 2022.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

The FDA has approved ICLUSIG® (ponatinib), the first and only kinase inhibitor in combination with chemotherapy indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL). Read More. 

Full prescribing information for ICLUSIG® will be posted here.

To learn more about ICLUSIG, please visit www.iclusig.com/hcp.

Breyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care.

In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with median duration of CR not reached, along with an established safety profile.

Breyanzi is now FDA approved for relapsed or refractory large B-cell lymphoma and CLL or SLL, bringing this differentiated CD19-directed CAR T cell therapy to more patients.  Read More

For more information, please see attached:

• Product information summary
• Policy considerations document that includes example coverage policy

Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Read More.

Full prescribing information for Brukinsa will be posted here.

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.