Drugs

Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication. Read More. 

Full prescribing information for Tivdak will be posted here.

Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions. Read More.

Full prescribing information for Ojemda will be posted here.

Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approvalExternal Link Disclaimer for this indication for adults in 2018.

This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs. Read More.

Full prescribing information for Lutathera will be posted here.

Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Read More.

Full prescribing information for Anktiva will be posted here.

Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Read More.

Full prescribing information for Alecensa will be posted here.

Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Read More.

Full prescribing information for Enhertu will be posted here.

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.