Industry News
The following section is additional information posted from our Corporate members to supplement product announcements.
2021
- From Merck: Merck has announced that WELIREG™ (belzutifan) 40-mg tablets has received FDA approval. WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Read the full press release HERE. Prescribing information can be found HERE.
- From BeiGene: BeiGene has announced that the FDA has approved zanubrutinib (Brukinsa) for adult patients with Waldenström’s macroglobulinemia (WM). Read the full press release HERE. Prescribing information can be found HERE.
- From Merck: Merck has announced that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. More information.
- From Astellas: On July 9, 2021, PADCEV’s indication was changed to treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. More information.
- From Bristol Myers Squibb: Bristol Myers Squibb has announced the FDA Approval of Opdivo® (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy. More information.
- From Oncopeptides: Oncopeptides has announced the most recent NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma Version 6.2021, effective April 12, 2021 which has designated Pepaxto® (melphalan flufenamide) as Category 2A. More information.
- From Merck: Merck announces that the FDA has approved KEYTRUDA® (pembrolizumab) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. More information.
- From Merck: Merck would like to advise you of a recent change to the Prescribing Information (PI) and Medication Guide for KEYTRUDA® (pembrolizumab) injection 100 mg. The detailed changes can be found here.
- From Bristol Myers Squibb: On April 16, 2021 the U.S. Food and Drug Administration approved Opdivo® (nivolumab) in combination with chemotherapy for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression. More information.
- From Bristol Myers Squibb: On March 26, 2021, U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T Cell Therapy for relapsed or refractory multiple myeloma. More information.
- 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
2018
- Gennetech - The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). Click here for more.
- Genentech announced the FDA granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. The Genentech press release including Important Safety Information is linked here. Click here for prescribing information.