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FDA APPROVALS

Complete List of FDA Oncology Approval Notifications

To see a complete list of FDA Oncology (Cancer) / Hematologic Malignancies Approval Notifications, visit the FDA's website.

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MSCO CORPORATE MEMBER APPROVALS

  • 15 Dec 2021 7:15 AM | Katy Monaco (Administrator)

    Bristol Myers Squibb announced that Orencia® (abatacept) was approved by the U.S. Food and Drug Administration (FDA) for the prophylaxis, or prevention, of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor (URD). More Information.

  • 06 Dec 2021 11:08 AM | Katy Monaco (Administrator)

    The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for KEYTRUDA as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older). More Information.

    Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information. The Medication Guide also is available.

    For prescribers: please click here for state-required price disclosures.

  • 02 Dec 2021 11:10 AM | Katy Monaco (Administrator)

    The U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.  More Information.

  • 23 Nov 2021 1:21 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).  More Information.

  • 17 Nov 2021 1:11 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.  More Information.

  • 02 Nov 2021 12:53 PM | Katy Monaco (Administrator)

    Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.   PD-L1 diagnostic testing is required prior to initiating treatment with KEYTRUDA in these patients.  More Information.


  • 01 Nov 2021 1:59 PM | Katy Monaco (Administrator)

    Novartis announced that the US Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. More Information.

  • 01 Nov 2021 9:32 AM | Katy Monaco (Administrator)

    Zanubrutinib has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) previously treated with at least one anti-CD20-based regimen.  More Information.

  • 15 Oct 2021 10:46 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. More information.

  • 13 Oct 2021 1:25 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.  More Information.

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