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Medicine vials and tablets
November 26, 2024|6 min read

Oncology Drug Reference Sheet: Lazertinib

Lazertinib (Lazcluze™), in combination with amivantamab, is the first and currently the only first-line chemotherapy-free combination treatment for adults with certain types of locally advanced or metastatic non-small cell lung cancer. 

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FDA Update 2024
November 15, 2024|6 min read

FDA Approves Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation

On November 15, 2024, the U.S. Food and Drug Administration (FDA) approved revumenib (Revuforj®), a menin inhibitor, for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients aged one year and older.

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October 29, 2024|5 min read

FDA Grants Asciminib Accelerated Approval for Newly Diagnosed Chronic Myeloid Leukemia

On October 29, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix®) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

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October 18, 2024|6 min read

FDA Approves Zolbetuximab-Clzb With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma

On October 18, 2024, the U.S. Food and Drug Administration (FDA) approved zolbetuximab-clzb (Vyloy), 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.

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October 11, 2024|7 min read

FDA Approves Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Variant, HR-Positive, HER2-Negative, Advanced Breast Cancer

On October 10, 2024, the U.S. Food and Drug Administration (FDA) approved inavolisib (Itovebi) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-variant, 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.

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September 20, 2024|4 min read

FDA Approves Isatuximab-Irfc With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa®) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation.

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September 20, 2024|5 min read

FDA Approves Amivantamab-Vmjw With Carboplatin and Pemetrexed for Non-Small Cell Lung Cancer With EGFR Exon 19 Deletions or L858R Variants

On September 19, 2024, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant®) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution variants whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

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September 17, 2024|5 min read

FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

On September 17, 2024, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

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September 17, 2024|6 min read

FDA Approves Ribociclib With an Aromatase Inhibitor and Ribociclib and Letrozole Co-Pack for Early High-Risk Breast Cancer

On September 17, 2024, the U.S. Food and Drug Administration (FDA) approved ribociclib (Kisqali®) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage II and III early breast cancer with a high risk for recurrence. Additionally, FDA approved the ribociclib and letrozole co-pack (Kisqali® Femara® Co-Pack) for the same indication.

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September 13, 2024|5 min read

FDA Approves Atezolizumab and Hyaluronidase-Tqjs for Subcutaneous Injection

On September 12, 2024, the U.S. Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for subcutaneous injection for all the adult indications for the IV formulation of atezolizumab (Tecentriq®), including non-small cell lung cancer (NSCLC), small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. 

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