Drugs

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.

FDA has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Revuforj. The New Drug Application (NDA) received approval through the FDA's Real Time Oncology Review (RTOR) program. Read More.

Food and Drug Administration approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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

Read More. 

Novartis is pleased to announce FDA approval of SCEMBLIX for adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

FDA approval was based on results from ASC4FIRST, a multicenter, randomized, active-controlled, open-label study that evaluated SCEMBLIX vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) (bosutinib, dasatinib, imatinib, nilotinib) in adult patients with newly diagnosed Ph+ CML-CP.

Read More.

FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.

Today, FDA also approved the VENTANA CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to identify patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with zolbetuximab.

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

Read More. 

FDA has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. Read More.

FDA has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors.

HYMPAVZI is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for the treatment of hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen. HYMPAVZI can offer a subcutaneous treatment option with a once-weekly dosing schedule and minimal preparation required for each individual administration.

Read More.

FDA approved ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers. Read More. 

We are sharing this communication on behalf of BeiGene USA, Inc. to announce WAC pricing and that the Centers for Medicare & Medicaid Services (CMS) has assigned a permanent drug-specific J-code TEVIMBRA® (tislelizumab‑jsgr) injection, for intravenous use, effective October 1, 2024.1 The J-code (J9329) and WAC are detailed below. Additionally, TEVIMBRA is now available.

Please see Indication and Important Safety Information below and click here to access the Full Prescribing Information for TEVIMBRA.

*NDC has been “zero‑filled” to ensure creation of an 11‑digit code that meets HIPAA standards.2 The zero‑fill location is indicated in bold. HIPAA=Health Insurance Portability and Accountability Act.

TEVIMBRA ® (tislelizumab-jsgr), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.3

The recommended dose of TEVIMBRA is 200 mg as an intravenous infusion once every 3 weeks. Administer the first infusion over 60 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.

Please see the full Prescribing Information for more information.

Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. 

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

Read More.