MOS Industry News
From Servier: On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved TIBSOVO® (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. With this approval, TIBSOVO is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML, and represents a major advancement for patients with newly diagnosed IDH1-mutated acute myeloid leukemia in the United States. here. To learn more, read the press release announcement HERE. May 25, 2022.
From Daiichi Sankyo: Daiichi Sankyo received approval by the US Food and Drug Administration (FDA) for Injectafer® (ferric carboxymaltose injection) for the treatment of iron deficiency anemia (IDA) in pediatric patients 1 year of age and older who have intolerance to oral iron or have had unsatisfactory response to oral iron. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. More information can be found in the press release.
From BeiGene: BeiGene announces findings from their Phase 3 ALPINE study, comparing zanubrutinib to ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic lymphoma (CLL) or small lymphocytic lymphoma (SLL). Click here for the press release. Questions regarding this information can be directed to BeiGene Medical Information at 1-833-969-2463, or firstname.lastname@example.org. For additional information on current FDA-approved indications for zanubrutinib, please see the Full Prescribing Information.
From Servier: Beginning February 14, 2022, there is a new NDC number for TIBSOVO® (72694-0617-60)*, the old NDC number was 71334-0100-01. SERVIER has new product packaging. The product itself remains the same. Listed here are pictures of the updated product packaging and ordering information.
From Pfizer: Pfizer receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment. Read more.
From Novartis: Novartis shares new survival data reported for women with HR+/HER2- metastatic breast cancer. Read more.
From AstraZeneca: AstraZeneca is excited to announce updated results from the positive PACIFIC Phase III trial showing Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit at five years in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy (CRT). Read the full press release.
From Sanofi: Sanofi is pleased to announce that SARCLISA® (isatuximab-irfc) is now approved, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. For more information, click here. Read the press release .
From EMD Serono Inc.: EMD Serono, Inc. is pleased to announce that on February 3, 2021 the U.S. Food and Drug Administration (FDA) approved TEPMETKO® (tepotinib). Please see Full Prescribing Information for TEPMETKO (tepotinib) for more information.
From Daiichi Sankyo and AstraZeneca: Daiichi Sankyo and AstraZeneca are excited to announce that ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for a new indication. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate that was recently approved for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. More information can be found here. Please be aware of the “Boxed Warnings” and other important safety information. For example, “ENHERTU has Boxed WARNINGS for Interstitial Lung Disease/Pneumonitis and Embryo-Fetal Toxicity. Please review full Prescribing Information for additional information.
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 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 Astellas and Seattle Genetics: Astellas and Seattle Genetics are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020. 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.