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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

  • September 20, 2024 9:16 AM | Katy Monaco (Administrator)

    FDA approved RYBREVANT® (amivantamab-vmjw) in combinationwith standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). Read More.

  • September 19, 2024 9:14 AM | Katy Monaco (Administrator)

    FDA has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Read More.

  • September 18, 2024 9:14 AM | Katy Monaco (Administrator)

    FDA has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease. Read More.

  • September 13, 2024 9:12 AM | Katy Monaco (Administrator)

    FDA has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab). It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer. Read More


  • August 20, 2024 12:48 PM | Katy Monaco (Administrator)

    FDA approved RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Read More.

  • August 19, 2024 12:47 PM | Katy Monaco (Administrator)

    AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. Read More.

  • August 16, 2024 12:44 PM | Katy Monaco (Administrator)

    FDA has approved Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.). Read More.

  • August 09, 2024 12:43 PM | Katy Monaco (Administrator)

    FDA has approved VORANIGO®, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection. VORANIGO is available and offers glioma patients the ability to actively manage their disease with the convenience of a once-daily pill.  Read More

  • August 08, 2024 10:58 AM | Katy Monaco (Administrator)

    Thank you for joining us in Chicago. We hope you were able to see that OPDIVO® (nivolumab) + YERVOY® (ipilimumab) and 2 cycles of chemotherapy* now has 5 years of follow-up data for PD-L1 <1% r/m NSCLC. Explore the data HERE and see why it may be time to reevaluate your current treatment approach.

    INDICATION

    OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

    Visit the website to learn more.

  • June 27, 2024 10:34 AM | Katy Monaco (Administrator)

    Genmab and AbbVie announce that the FDA has approved  EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s). Read More


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