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May 05, 2022
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Top in hem/onc: FDA designations for breast cancer, multiple myeloma treatments

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The FDA recently granted breakthrough therapy designation of a HER2-directed antibody drug conjugate for the treatment of certain adults with unresectable or metastatic HER2-low breast cancer.

The designation applies to patients who previously received a systemic therapy in the metastatic setting or experienced disease recurrence during or within 6 months of adjuvant chemotherapy, according to the FDA. It was the top story in hematology/oncology last week.

FDA HQ in Washington
Source: Adobe Stock

The FDA also recently granted orphan drug designation to an off-the-shelf chimeric antigen receptor T-cell therapy for adults with advanced multiple myeloma. This was the second top story.

Read these and more in hematology/oncology below:

Enhertu receives breakthrough therapy designation for breast cancer subset

The FDA granted breakthrough therapy designation to Enhertu (fam-trastuzumab deruxtecan-nxki; AstraZeneca, Daiichi Sankyo) for the treatment of adults with unresectable or metastatic HER2-low breast cancer, according to a press release from the agent’s manufacturer. Read more.

FDA grants orphan drug designation to off-the-shelf CAR-T for advanced multiple myeloma

The FDA granted orphan drug designation to ALLO-605 (Allogene Therapeutics) for adults with relapsed or refractory multiple myeloma. Read more.

Should insurance companies cover medical marijuana for cancer pain?

Cannabis was a legal and popular medicine in the United States until the Marihuana Tax Act in 1937, when it was criminalized, over the vigorous objections of the AMA, primarily for reasons related to racism and competitive commercial interests. Read more.

Donor socioeconomic status affects hematopoietic stem cell transplant outcomes

Socioeconomic disadvantage among hematopoietic stem cell transplant donors appeared associated with poorer outcomes among transplant recipients, according to study results. Read more.

Early lung cancer detection improves survival rates

The American Cancer Society estimated the numbers of new cancer cases and deaths in the United States, projecting nearly 2 million new cancer cases and more than 600,000 deaths in 2022. Read more.