ISCO Industry News:

From Seagen:  Seagen is excited to share new PFS information. Contact Carla Taylor with Seagen Inc. for additional information and questions.

From AstraZeneca: AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Find out more.

From Gilead: Gilead has announced that CMS has issued a new J-Code for TRODELVY (sacituzumab govitecan-hziy) and published the payment limits and the NDC to HCPCs cross-walk file on their website.Effective for dates of service on or after January 1, 2021, the new HCPCS code for TRODELVY is J9317 and the billing increment is 2.5 mg. Find out more.

From AstraZeneca: AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for an additional dosing option for patients with a body weight of 30 kg and more: 1500 mg administered intravenously every four weeks in the approved indication of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT). Patients with body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks. Learn more in AstraZeneca’s press release here. Click here for Important Safety Information.

From Janssen Pharmaceutical Companies of Johnson & Johnson: On December 3, 2020, Janssen announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for amivantamab, an investigational, fully-human epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications. Find out more.

From AstraZeneca: AstraZeneca announces important dosing information for unresectable Stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy. Options are available for weight-based 2-week or fixed 4-week dosing with IMFINZI, allowing patients to receive IMFINZI at the frequency that best suits their schedules. Find out more.

From AbbVie: AbbVie announces that the U.S. Food and Drug Administration has granted full approval of VENCLEXTA® (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Find out more.

From Immunomedics: Immunomedics announces a new C-Code (C-9066) for Trodelvy (sacituzumab govitecan-hziy), a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.The C-Code is effective October 1, 2020. Find out more.

From Lilly: As part of a national initiative to improve access to newly approved treatments, Lilly Oncology is offering a free thyroid testing program to help determine if patients have a genetic alteration that may inform therapeutic decisions. Please review the details outlined here and save this form to request a test for your patient as the need arises.

From Incyte: On August 7, 2020, the U.S. Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. Find out more.

From Takeda: Takeda is pleased to announce that the US Food and Drug Administration (FDA) has approved the label expansion for ALUNBRIG® (brigatinib) to include patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive. ALUNBRIG is indicated for the treatment of adult patients with ALK+ metastatic NSCLC as detected by an FDA-approved test. Please click here to review full prescribing information on ALUNBRIG. Click here for important safety information.

From Taiho Oncology: Taiho Oncology is excited to share that INQOVI®, (decitabine and cedazuridine) tablets, approved in July 2020, (https://www.taihooncology.com/us/news/2020-07-inqovi-approval/) is now available. Please click HERE for more information.

 

The following section is additional information posted from our Corporate members to supplement product announcements.

2021

  • From Pfizer: On February 9, 2021, Pfizer received FDA approval for the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of ZIRABEV® (bevacizumab-bvzr). More information.
  • From Oncopeptides, Inc.: Oncopeptides, Inc. is pleased to announce the U.S. Food and Drug Administration has granted approval for PEPAXTO® (melphalan flufenamide). For more information, please see the full Prescribing Information and press release.
  • From Bristol Myers Squibb: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. More Information.
  • From Bristol Myers Squibb: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration has approved OPDIVO® (nivolumab) in combination with CABOMETYX® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma. More Information.
  • From Pfizer: Pfizer Oncology is proud to announce a new FDA-approved indication for XALKORI® (crizotinib) capsules. The following information is available for State Society review: Full Prescribing Information. Press Release.

2020

  • From Merck: KEYTRUDA has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. More information.
  • On May 7, 2020, the Centers for Medicare and Medicaid Services (CMS) released the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule, which clarifies CMS policy regarding the use of copay accumulator programs by certain individual market and group health plans.1  The Final Rule allows issuers and plans to use copay accumulators to exclude the value of a coupon for a brand name drug from an enrollee’s annual cost sharing limit, even when there is no medically appropriate generic equivalent available, if doing so is permitted  under state law. Click here to read more.
  • Janssen Oncology shares five resources: Medicare Part D For Patients with Prostate Cancer, Medicare Part D Extra Help/Low-Income Subsidy (LIS) for Patients with Prostate Cancer, 2021 Medicare Open Enrollment MEDIGAP Considerations, Medicare Advantage and Part D Prescription Drug Coverage, and Health Plans in the Insurance Marketplace.
  • Bristol Myers Squibb announces that on September 1, 2020, the FDA approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy. AML is one of the most common acute leukemias in adults. More information. September 1, 2020.
  • Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (DECITABINE AND CEDAZURIDINE) tablets, oral hypomethylating agent (HMA) therapy for intermediate and high-risk MDS and CMML. Click for more information.
  • Merck announces a change from CMS regarding ONTRUZANT®(trastuzumab-dttb), for injection, for intravenous use 21 mg/mL, which has a Q-code of Q5112.  As of July 2020, Centers for Medicare & Medicaid Services (CMS) has issued a Corrected Addendum B to update the non-payable status for ONTRUZANT (Q5112) to Status Indicator “K”, which allows for Medicare reimbursement and is retroactive to April 15, 2020. Click to read Addendum A and Addendum B from CMS. Click here to review the "July 2020 Correction" for Addendum B.
  • Merck announces that the FDA has approved KEYTRUDA® (pembrolizumab) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).  Click here for more information.
  • Genentech announces that TECENTRIQ® (atezolizumab), in combination with bevacizumab, has been approved by the FDA for the first-line (1L) treatment of unresectable or metastatic hepatocellular carcinoma (HCC) treatment. Click for information on TECENTRIQ and AVASTIN. Click here for important safety information. Click
  • Merck announces  that a Medicare Medically Unlikely Edit (MUE) value has been modified for KEYTRUDA® (pembrolizumab).  The MUE for KEYTRUDA was modified effective July 1, 2020. A list of quarterly Procedure-to-Procedure and MUE version update changes from CMS can be found here.
  • Merck announces that KEYTRUDA® (pembrolizumab) injection 100 mg has been approved by the FDA for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Click here for more.
  • AstraZeneca and Daiichi Sankyo, Inc. announce permanent Jcode effective July 1st for ENHERTU. Click here for more.
  • Pfizer is announcing preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic. The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen for potential publication. Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.  More information.
  • Genentech, Inc. announces that on June 29, 2020, the Food and Drug Administration (FDA) approved PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use. PHESGO is a fixed-dose combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase,
    an endoglycosidase.1  More information.
  • EMD Serono and Pfizer Inc. announces that on June 30, 2020 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication.  BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc. Please  refer to the revised Full Prescribing Information for BAVENCIO.
  • Johnson & Johnson: Key Takeaways: FY 2021 Medicare Hospital  Inpatient Prospective Payment System (IPPS) Proposed Rule: Chimeric Antigen Receptor (CAR) T-Cell Therapy and Hospital Market-Based Data Reporting.  Comments due July 10, 2020.  Click here for more information.
  • Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg. The new and unique J-code replaces all previous HCPCS codes for crizanlizumab-tmca (Adakveo®, Novartis) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types. Click here for more information.  June 15, 2020.
  • Bristol Myers Squibb announces that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) 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. More information. May 26, 2020
  • Merck Sharp & Dohme Corp. ("Merck") announces that ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use 21 mg/mL, a biosimilar* to Herceptin® (trastuzumab), is available through specialty distributors and wholesalers. Please contact your specialty distributor or wholesaler to confirm product availability.  More Information. April 21, 2020.
  • AstraZeneca Pharmaceuticals announces a webinar entitled "IMFINZI® (durvalumab) in Combination with Chemotherapy for the Treatment of ES-SCLC, on April 21, 2020, Find out more.
  • AstraZeneca Pharmaceuticals announces IMFINZI® (durvalumab) sample treatment plan template for the first-line treatment of adult patients with extensive-stage small cell lung cancer in combination with etoposide and either carboplatin or cisplatin as an example of an Electronic Health Record (EHR) order set, Find out more.
  • Pfizer Oncology is pleased to announce that IBRANCE® (palbociclib) is transitioning from capsules to tablets. Click here for more.
  • Novartis is pleased to announce that, effective April 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific C-code, C9053 for 100 mg/10 mL (10 mg/mL) solution in a single-dose vial of ADAKVEO® (crizanlizumab-tmca) for IV infusion. Click here for more.
  • On February 18, 2020, 106 organizations representing patients, providers, medical researchers, survivors, and families joined together to urge Congress to include the bipartisan CLINICAL TREATMENT Act (H.R. 913) in the upcoming ‘must pass’ healthcare extenders package, which is expected to pass this spring.  Find out more
  • Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for POLIVY™ (polatuzumab vedotin-piiq). POLIVY received FDA approval on June 10, 2019: Click here for more.

2019