The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has been approved by the FDA for adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who received prior neoadjuvant or adjuvant chemotherapy. The drug was previously approved for treatment of adults with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who received chemotherapy in the neoadjuvant, adjuvant, or metastatic...

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

Sacituzumab govitecan-hziy (Trodelvy – Gilead) has been approved for treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who received prior endocrine therapy and ≥2 additional systemic therapies for metastatic disease. It was previously approved for treatment-refractory metastatic triplenegative breast cancer and for treatment of locally advanced or metastatic urothelial cancer in adults who received platinum-based chemotherapy and a programmed death receptor-1...

The FDA has approved avelumab (Bavencio – EMD Serono) and durvalumab (Imfinzi – AstraZeneca), two new immune check point inhibitors, and pembrolizumab (Keytruda – Merck), a checkpoint inhibitor that has been available in the US since 2014, for treatment of locally advanced or metastatic bladder cancer. Nivolumab (Opdivo) and atezolizumab (Tecentriq) were approved earlier for this indication.

The FDA has approved afatinib (Gilotrif — Boehringer Ingelheim), an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations occur in about 10% of patients with NSCLC. Afatinib is the second EGFR inhibitor to be approved for first-line treatment of advanced lung cancer. The first was erlotinib (Tarceva), which is also approved for treatment of patients with locally advanced...

The FDA has approved lutetium lu 177 vipivotide tetraxetan (Pluvicto – Novartis) for treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adults previously treated with androgen receptor (AR) pathway inhibitors and taxane-based chemotherapy.

Mirvetuximab soravtansine-gynx (Elahere – Immuno-Gen), an antibody-drug conjugate, has received accelerated approval by the FDA for treatment of folate receptor (FR) alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy. Accelerated approval was based on the overall response rate and median duration of response.

The FDA has approved a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase (Phesgo – Genentech) for use in combination with chemotherapy for neoadjuvant (preoperative) treatment of human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early-stage breast cancer, or for adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence, or with docetaxel for treatment of those with HER2-positive metastatic breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic disease....

The oral kinase inhibitor osimertinib (Tagrisso – AstraZeneca), which has been available for years for treatment of non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, has now been approved for treatment of unresectable stage III EGFR-mutated NSCLC. About 20-30% of patients with NSCLC have locally advanced stage III NSCLC, and 60-90% of these patients have unresectable disease. Osimertinib is the first targeted therapy to be approved for the new indication.

Direct-to-consumer advertisements are urging women to be tested for mutations in BRCA1 and BRCA2 genes, which are the most common known causes of an inherited predisposition to breast and ovarian cancer. Clinically important BRCA mutations have been found in about 2% of Ashkenazi Jewish women, and are estimated to occur in about 1 in 300 to 500 women in the general non-Jewish US population. The prevalence appears to be lower in non-whites.