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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

  • June 17, 2024 10:48 AM | Katy Monaco (Administrator)

    AstraZeneca’s Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

    The approval by the Food and Drug Administration (FDA) was based on the results of a prespecified exploratory subgroup analysis by MMR status in the DUO-E Phase III trial. Results from DUO-E were published in the Journal of Clinical Oncology.

    Read More.

  • June 14, 2024 10:49 AM | Katy Monaco (Administrator)

    Amgen today announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. Read More.

  • June 14, 2024 10:46 AM | Katy Monaco (Administrator)

    Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.1 The approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors.1 This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1  

    Read More

  • June 13, 2024 11:55 AM | Katy Monaco (Administrator)

    Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

    Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020.

    Full prescribing information for Retevmo will be posted on Drugs@FDA.

    Read More

  • June 10, 2024 10:30 AM | Katy Monaco (Administrator)

    Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). Read More.

    Full prescribing information for Rytelo will be posted here.

  • June 03, 2024 12:46 PM | Katy Monaco (Administrator)

    Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). Read More.

    Full prescribing information for Breyanzi will be posted here.

  • May 31, 2024 12:45 PM | Katy Monaco (Administrator)

    On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following:

    • advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy;
    • advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate); and
    • locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

    This is the first FDA approval of a targeted therapy for pediatric patients < 12 years of age with RET alterations. Selpercatinib was previously granted accelerated approval for the thyroid cancer indications in adults and pediatric patients 12 years of age and older. It also was previously granted accelerated approval for the solid tumor indication in adults.

    Read more.

    Full prescribing information for Retevmo will be posted here.

  • May 29, 2024 8:53 AM | Katy Monaco (Administrator)

    U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) for zanidatamab (Jazz Pharmaceuticals), the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). Read More.

  • May 24, 2024 12:42 PM | Katy Monaco (Administrator)

    Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Read more

    Full prescribing information for Breyanzi will be posted here.

  • May 17, 2024 10:45 AM | Katy Monaco (Administrator)

    FDA has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Read More.


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