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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

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  • February 18, 2025 11:04 AM | Katy Monaco (Administrator)

    FDA has approved the supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.

    For more detailed information, please see the Full ADCETRIS Prescribing Information, including Boxed Warning.

    Read More >

  • February 17, 2025 11:05 AM | Katy Monaco (Administrator)

    FDA has approved ROMVIMZA™ (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. The FDA previously granted Fast Track designation and Priority Review for ROMVIMZA, which was developed by Deciphera Pharmaceuticals, Inc. (“Deciphera”), a wholly owned subsidiary of Ono.

    Read More >

  • January 21, 2025 10:38 AM | Katy Monaco (Administrator)

    FDA has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC).

    Read More.

  • January 17, 2025 10:39 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

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

    Read More.

  • January 17, 2025 10:37 AM | Katy Monaco (Administrator)

    AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.

    The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. It was based on results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress.

    Read More.

  • January 09, 2025 10:26 AM | Katy Monaco (Administrator)

    FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.i The indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. This accelerated approval is among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease. 

    Read More.

  • January 06, 2025 2:00 PM | Katy Monaco (Administrator)

    FDA granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.1,2 The approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures, similar efficacy in overall response rate (ORR), and showed a comparable safety profile vs. intravenous (IV) Opdivo.  Read More

  • January 03, 2025 8:22 AM | Katy Monaco (Administrator)

    FDA has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1). 

    Read More

  • December 19, 2024 10:31 AM | Katy Monaco (Administrator)

    AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

    The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the ADRIATIC Phase III trial which were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine.

    Read More.

  • November 21, 2024 9:54 AM | Katy Monaco (Administrator)

    FDA accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 The Phase 3 HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC. Read More.

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