Zanidatamab

Starting January 1, 2025, Independence Blue Cross updates specialty drugs requiring precertification for certain plans. Includes FDA-approved drugs like Ahzantive, Bkemv, and pending approval drugs. Updates also reflect brand name changes for previously added drugs.

In 2024, the FDA approved over 60 oncology therapies, including 11 first-in-class drugs. Highlights include Revumenib and Zolbetuximab for leukemia and gastric cancer, respectively, and new treatments targeting HER2, PD-L1, and ALK with improved efficacy and reduced toxicity. The approvals also featured novel strategies like bispecific antibodies and CAR T-cell therapies, alongside new indications for existing drugs.

In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.

Zanidatamab combined with evorpacept showed promising antitumor activity in HER2-positive and HER2-low metastatic breast cancer patients, including those heavily pretreated, in a phase 1b/2 study presented at the 2024 SABCS.

Zanidatamab, the first HER2 bispecific antibody, received FDA accelerated approval for second-line biliary tract cancer. It shows improved response rates over existing treatments, offering new hope for HER2-positive patients. BeiGene plans to fast-track its approval in Korea, aiming for orphan drug designation.

MSKCC advanced cancer treatments in 2024 include new surgical techniques, vaccines, drugs enhancing radiation, and diagnostic tools. The FDA approved 11 drugs based on MSK's pivotal clinical trials, covering new uses for existing drugs, effective drug combinations, engineered cell therapies, and novel targeted therapies. Key developments include a KRAS vaccine for pancreatic and colorectal cancer, combination drug-radiation treatment for basal cell carcinoma, noninvasive E-nose for lung cancer detection, improved transplant success with partially matched donors, exercise impact on prostate cancer biomarkers, new imaging for lung and prostate cancers, TIL therapy for non-small cell lung cancer, robotic neurosurgery for spinal tumors, avoiding surgery for HPV throat cancer with innovative radiation, imlunestrant for ER+, HER2- advanced breast cancer, mRNA vaccine for pancreatic cancer, and immunotherapy for rectal cancer. FDA approvals included tepotinib for METex14 lung cancer, CAR T treatment for mantle cell lymphoma, selpercatinib for RET-linked thyroid cancer, repotrectinib for NTRK fusion cancers, adagrasib with cetuximab for KRAS-G12C colorectal cancer, afamitresgene autoleucel for synovial sarcoma, vorasidenib for IDH glioma, inavolisib with fulvestrant and palbociclib for breast cancer, revumenib for KMT2A leukemia, zanidatamab for HER2 biliary tract cancer, and zenocutuzumab for NRG1 fusion pancreatic and lung cancers.

10 biotech companies to watch in 2025: Anavex Life Sciences (blarcamesine for neurodegenerative diseases), Candid Therapeutics (T cell engager antibodies for autoimmune diseases), Enterprise Therapeutics (ETD001 for cystic fibrosis), Jazz Pharmaceuticals (Ziihera for biliary tract cancer), Life Biosciences (ER-100 for optic neuropathies), Ovid Therapeutics (OV888 for cerebral cavernous malformation), Skye Bioscience (nimacimab for obesity), TG Therapeutics (Briumvi for multiple sclerosis), Wave Life Sciences (WVE-006 for alpha-1 antitrypsin deficiency), and Quotient Therapeutics (somatic genomics platform for drug discovery).

The FDA accelerated approval of zanidatamab-hrii (Ziihera) for previously treated HER2-positive biliary tract cancer fills a treatment gap. The phase 2b HERIZON-BTC-01 trial supported the approval with a 52% objective response rate and median duration of response of 14.9 months. Zanidatamab, a novel bispecific HER2-targeted antibody, offers a new treatment option for this difficult-to-treat disease, with ongoing evaluations in frontline therapy.

ALX Oncology will host a webcast on December 17, 2024, at 8:00 AM EST to discuss Phase 1b/2 clinical trial data for evorpacept combined with zanidatamab in metastatic breast cancer treatment. Alberto J. Montero, MD, MBA, will present data from SABCS 2024. The event is accessible via ALX Oncology's website.

Jazz Pharmaceuticals received FDA approval for Ziihera, a HER2-targeted therapy for HER2+ biliary tract carcinoma, with a list price of $35,500 per cycle. Piper Sandler reaffirmed its Overweight rating and $163 price target, highlighting growth in the oncology segment. Jazz's strong financial health supports portfolio expansion, with anticipation for 2025 data on Ziihera in first-line HER2+ gastroesophageal adenocarcinoma.