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RECENT UPDATES & APPROVALS

Drugs


A carefully crafted resource to ensure that oncology professionals stay up-to-date with the most recent drug updates and FDA approvals. Here, you'll discover a collection of vital information, enabling you to make well-informed choices and provide advanced care to your patients. Keep up with the ever-changing world of oncology treatments with our extensive updates, guaranteeing that your practice stays at the forefront.


Drug Updates

To view current and resolved drug shortages and discontinuations reported to the FDA, click here.

  • Geron's RYTELO™ (imetelstat) Received Permanent J-Code (Effective Janaury 1, 2025)

We are pleased to share the permanent J-code for RYTELO™ (imetelstat). For dates of service on or after January 1, 2025, use J-code J0870 when submitting claims for RYTELO. The permanent J-code enables providers and office staff to code with specificity, for claims processing purposes, after RYTELO is administered to a patient.1

Permanent J-Code

Description

Sites of Care

J0870

Injection, imetelstat, 1 mg

All

 

10-digit NDC2

11-digit NDC

Vial Size

Billing Units

82959-112-01

82959-0112-01

One RYTELO 47 mg

single-dose vial

47

82959-111-01

82959-0111-01

One RYTELO 188

mg single-dose vial

188

Please consider updating your billing software to reflect the permanent J-code J0870, units: 1 unit per 1 mg, and expected reimbursement for use on or after January 1. 2025.

Click here to learn more about RYTELO.

Please see full Prescribing Information, including Medication Guide.

  • AstraZeneca's TRUQAP Blister Pack Launch

AstraZeneca is thrilled to share late-breaking news regarding the availability of TRUQAP. The AstraZeneca Trade Ops team has been hard at work and is happy to report that TRUQAP blister packs are available for ordering from the Big 3 Specialty Distributors starting Monday, October 28.

  1. MCKESSON – Product is available to customers. Should a customer not see the product visible in the ordering system, please ask that they call their purchasing contact at McKesson.
  2. CENCORA – Product is available to customers via their portal.
  3. CARDINAL – Product is available to customers via their portal.

Pharmaceutical Buyer Letter

Notice To 340 B Covered Entities Regarding Truqap 

Blister Pack Leave Behind

  • NTAP Now Available for Johnson & Johnson's TALVEY® (talquetamab-tgvs)

Johnson & Johnson Health Care Systems Inc. submitted an application to the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-On Payment (NTAP) for TALVEY® for Federal Fiscal Year (FFY) 2025. On August 1, 2024, CMS approved 5 NTAP applications for technologies, including the application for TALVEY®, in the Inpatient Prospective Payment System final rule.

Effective October 1, 2024, TALVEY® is eligible for a New Technology Add-On Payment (NTAP).

For more details related to the NTAP now available for TALVEY®, please click here.  

FDA Approvals

  • March 22, 2024 2:17 PM | Katy Monaco (Administrator)

    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.


  • March 22, 2024 2:02 PM | Katy Monaco (Administrator)

    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.

  • March 15, 2024 11:24 AM | Katy Monaco (Administrator)

    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:

  • March 11, 2024 2:15 PM | Katy Monaco (Administrator)

    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.

  • March 08, 2024 2:13 PM | Katy Monaco (Administrator)

    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.

  • March 08, 2024 1:03 PM | Katy Monaco (Administrator)

    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.

  • March 04, 2024 8:54 AM | Katy Monaco (Administrator)

    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.

  • February 23, 2024 8:53 AM | Katy Monaco (Administrator)

    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.

  • February 22, 2024 11:12 AM | Katy Monaco (Administrator)

    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.

  • February 20, 2024 1:21 PM | Katy Monaco (Administrator)

    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.


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